Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA

Shots:

  • Roche has reported the data from the dose-finding Part 1 of the FIREFISH study assessing Evrysdi in patients aged 1-7mos. with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2
  • Part 1 data demonstrated that 99% of infants survive without permanent ventilation @12 mos. & 33% sit without support for at least 5sec. In an exploratory analysis, 41% received high dose, 53% achieved upright head control, and 6% were able to stand as assessed by the HINE-2., 86% were able to feed orally
  • The researcher also assessed motor function with CHOP-INTEND & demonstrated that 52% achieved a CHOP-INTEND score of ≥40 points

Click here ­to­ read full press release/ article | Ref: Roche | Image: Forbes

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MatriSys Report Results of MSB-0221 in P-I study for the Topical Treatment of Atopic Dermatitis

Shots:

  • The P-I trial involves assessing MSB-0221 (ShA9) or vehicle applied topically on forearm skin in 54 adults with staphylococcus aureus-positive AD for 1week
  • The expression of mRNA for psmα was inhibited from S. aureus isolated from all participants while the correlation was observed within 7days b/w improvement in local eczema severity and killing of S. aureus
  • In general, the results showed the safety and potential benefits of bacteria to treat chronic skin diseases. Additionally, the company plans to conduct a P-II clinical trial that will evaluate MSB-0221 vs PBO in 150 patients over a 12wks. treatment period to treat AD

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Owler

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AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis

Shots:

  • The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC
  • The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response @8wks. & @2wks. (74% vs 25% & 63% vs 26%); endoscopic improvement (44% vs 8%); histologic endoscopic mucosal improvement (37% vs 6%)
  • The safety results were consistent with the previous P-III induction study, with no new safety risks observed. Rinvoq is a selective and reversible JAK inhibitor, being studied as an oral therapy for mod. to sev. UC and several other immune-mediated diseases

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Top Employers Institute

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Astellas Reports Results of Fezolinetant in Two P-III Studies for the Nonhormonal Treatment of VMS in Postmenopausal Women

Shots:

  • The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods
  • Both the trials met all four co-1EPs demonstrating a significant reduction from baseline in the frequency and severity of moderate to severe VMS to week 4 and week 12
  • Fezolinetant is an NK3R antagonist targeting NKB binding on the KNDy neuron to moderate neuronal activity in the brain to treat VMS associated with menopause

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Nasdaq

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Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

Shots:

  • The P-III PSOARING 3 is an OLE study assessing Tapinarof (1%) in patients with plaque psoriasis for ~40wks. and a 4wks. safety follow-up period
  • The interim analyses showed 57.3% of study participants who entered the study with a PGA of ≥ 2 achieved a PGA of 0 or 1 while 39.2% achieved PGA 0 and the results were consistent with the previous studies. The findings will be included in NDA submission expected in mid-2021 and completion of PSOARING 3 study in H1’21
  • In an integrated analysis, 63.5% & 44.2% of subjects achieved PASI7 & 90 with the improvement in treatment effect beyond 12wks. Remittive effect of ~4mos. following treatment, discontinuation was observed

Click here ­to­ read full press release/ article | Ref: Dermavant | Image: Business Wire

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Lilly Reports Results of Tirzepatide in P-lll SURPASS-3 and 5 Trials for Type-2 Diabetes

Shots:

  • The P-lll SURPASS-3 study involves assessing Tirzepatide (5/10/15 mg) vs titrated insulin degludec in 1444 participants in a ratio (1:1:1:1) with T2D treated with metformin with or without an SGLT-2 inhibitor for 52wks.
  • The P-lll SURPASS-5 study involves assessing Tirzepatide (5/10/15 mg) vs PBO in 475 participants in a ratio (1:1:1:1) in adults with inadequately controlled T2D already being treated with insulin glargine with or without metformin
  • The SURPASS-3 & 5 shows A1C reduction: (-1.93% /-2.20%/-2.37% vs- 1.34%) & (-2.23%/-2.59%/ -2.59% vs -0.93%); Weight reduction: (-8.1%/ -11.4%/-13.9% vs +2.7%) & (-6.6%/-8.9%/-11.6% vs +1.7%) respectively

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Fortune

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Novartis Report Results of Kesimpta (ofatumumab) Sensoready autoinjector pen for Multiple Sclerosis

Shots:

  • The multicenter survey involves assessing Kesimpta Sensoready autoinjector pen in 80 MS patients and 50 MS nurses, with RMS who received a disease modifying treatment through a subcutaneous/intramuscular injection via an autoinjector
  • The result shows MS patients and nurses prefer the Kesimpta Sensoready autoinjector pen over other autoinjectors for current treatment (84% vs 16%). The findings will be presented at the ACTRIMS Forum 2021 on Feb, 2021
  • Kesimpta received positive CHMP opinion last month based on two P-III trials showed reduction of annual relapses by over 50% with more than 30% relative risk reduction of 3 mos. CDP vs teriflunomide

Click here ­to­ read full press release/ article | Ref: Novartis | Image: PMLiVE

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Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

Shots:

  • The P-II SWOG S1500/PAPMET trial involves assessing cabometyx (60 mg, qd with dose reductions to 40 & 20mg ), crizotinib, and savolitinib vs sunitinib in a ratio (1:1:1:1) for patients with advanced or metastatic PRCC
  • The results demonstrated significant improvement in PFS. The trial met its 1EP’s shows mPFS (9.0 mos. vs 5.6 mos.); ORR (23% vs 4%) mOS (20.0 mos. vs 16.4 mos.)
  • The findings were presented at the 2021 ASCO GU and simultaneously published in The Lancet

Click here ­to­ read full press release/ article | Ref: Exelixis | Image: Exelixis

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Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots:

  • The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies
  • The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% in SOT recipients), (55.9% vs 20.8% in HCT recipients), CMV clearance regardless of baseline viral load category (62.1% & 43.9% vs 24.7% & 21.9%), CMV viremia clearance and symptom control in transplant recipients @16wks. (18.7% vs 10.3%)
  • The company is committed to advancing the care of vulnerable transplant recipients, and if approved, Maribavir will be the 1st and only treatment indicated for post-transplant r/r cmv infection

Click here ­to­ read full press release/ article | Ref: Takeda | Image: The Boston Globe

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Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

Shots:

  • The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs aflibercept (2mg, fixed 2mos. intervals) in 1891 patients with DME
  • The P-III TENAYA & LUCERNE studies assessing faricimab (6mg administered at fixed intervals of every 2,3 & 4mos. based on objective assessment of disease activity @20 & 24wks.) vs aflibercept in 1329 patients with nAMD
  • The studies showed, i.e faricimab demonstrated non-inferior visual acuity gains and shows greater reductions in CST, thus reducing the treatment burden for patients and was well tolerated with no new safety signals identified

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pharmaceutical Technology

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BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma

Shots:

  • The P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or metastatic RCC
  • Results: @median follow-up of two years (23.5 mos.); median PFS (17.0 vs 8.3mos.), ORR (54.8% vs. 28.4%); Disease control rate (88.2% vs. 69.9%); CR (9.3% vs 4.3%); OS (34% reduction in risk of death). In an exploratory subgroup analysis of 75 patients with sarcomatoid features, 64% reduction in risk of death, PFS (10.3 vs 4.2mos.); ORR (55.9% vs 22.0%)
  • The findings showing ongoing efficacy benefits and patient-reported outcomes will be presented at the 2021 Genitourinary Cancers Symposium

Click here ­to­ read full press release/ article | Ref: BMS | Image: BMS

The post BMS Report Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III CheckMate -9ER Trial for 1L Treatment of Advanced Renal Cell Carcinoma first appeared on PharmaShots.

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Shots:

  • The P-II AMBER2 study assessing the efficacy and safety of SHR0302 (8mg qd/4mg bid/4mg qd) vs PBO in 164 adults with moderate to severe UC across 84 sites in China, US, and EU. The AMBER2 study consisted of an 8wks. induction period, followed by an 8wks. extension period
  • The study met its 1EPs i.e. percentage of patients who achieved a clinical response per the 9-point Mayo Score (46.3%/46.3%/43.9% vs 26.8%) @8wks., improvement in patients (22%/24.4%/24.4 vs 4.9%) respectively
  • SHR0302 is a potent and highly selective JAK1 inhibitor. The company expects to initiate the P-III program in 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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Veklury rescues Gilead from COVID doldrums in Q4

Gilead’s COVID-19 drug Veklury (remdesivir) is helping the company through disruption caused by the pandemic and patent expiry on two HIV drugs, according to its Q4 results announcement.

In the final quarter alone, Veklury generated sales of just over $1.9 billion, offsetting a downturn in sales elsewhere in the business amid the disruption to healthcare services caused by COVID-19.

Product sales excluding the drug were down 7% compared with last year’s Q4, to just under $5.4 billion.

But with the COVID-19 drug sales factored in, the California pharma’s sales came to $7.3 billion, a 26% increase.

Veklury was one of the first drugs to treat the disease approved by the FDA using an Emergency Use Authorization and received its full licence in October last year.

In a conference call to discuss the results, CEO Daniel O’ Day noted that the company had already updated its guidance last month as a result of the “significant increase in the uptake of Veklury” in the US.

He noted that Veklury also helped to offset the impact of generic competition for its old HIV drugs, Atripla and Truvada, which lost their patient protection in October.

He said: “In the United States alone, hospitalisations quadrupled between October and January. And approximately one out of every two patients hospitalised in the US are being treated with Veklury today.”

He noted data from ACTT-1 trial showing the drug reduced hospitalisation time by five days on average.

O’Day said: “The higher uptick of Veklury, along with the continued growth of our leading treatment for HIV, Biktarvy, helped to offset the ongoing impact to the pandemic on some parts of our business. Veklury and Biktarvy also helped to mitigate the expected impact of loss of exclusivity for Atripla and Truvada in October.”

Sales of Veklury were mainly based in the US, where revenues were $1.2 billion in Q4 alone, with sales of $547 million in Europe and $150 million in the rest of the world.

It remains to be seen whether Veklury will gain traction outside the US and Europe, as the separate Solidarity trial from World Health Organization found it had little or no effect on length of hospital stay or mortality in preliminary results announced in October.

The company has increased its quarterly dividend by 4.4% to $0.71 per share of common stock.

The post Veklury rescues Gilead from COVID doldrums in Q4 appeared first on .

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Shots:

  • The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints
  • Results: The level of protection against mod-to-severe COVID-19 infection was 72% in the US, 66% in Latin America, 57% in South Africa; 28 days post-vaccination and 85% effective in preventing severe disease and complete protection & death as of day 28
  • The company plans to provide affordable COVID-19 vaccine at a not-for-profit basis for emergency pandemic use, pending regulatory authorizations

Click here ­to­ read full press release/ article | Ref: J&J | Image: M3 India

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Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Shots:

  • The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1
  • Results: @ median follow-up (20.6 mos.); mOS (21.4 vs 21.9 mos.); mPFS (8.2 vs 8.4 mos.); ORR (45.4%); mDOR (16.1 mos.); RMST ( -0.56 and -0.52) @24 mos.
  • The results were presented in the Presidential Symposium at the World Conference on Lung Cancer 2020 Presidential Symposium and published in the Journal of Clinical Oncology

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: AP News

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Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots:

  • The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC
  • Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage among all responders was 60% and complete responses observed
  • Sotorasib is 1st KRAS G12C Inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Fierce Pharma

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BioInvent Report Results of BI-1206 + Rituximab in P- I/IIa Study for Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

Shots:

  • The P- I/IIa study assess BI-1206 + rituximab in patients with indolent r/r B-cell NHL. The study consists of 2 parts: P- l with dose escalation cohorts using a 3+3 dose-escalation and selection of the recommended RP2D and P-IIa which is an expansion cohort at the RP2D enriched with MCL patients
  • The results showed responses in 6/9 patients demonstrating BI-1206 has ability to restore activity of rituximab in NHL patients who have relapsed after treatment with rituximab
  • Long-lasting complete responses observed in two patients beyond 12mos. The company has initiated P- I/IIa trial of BI-1808 in Jan’2020 and will initiate P- l/lla study of BT-001 in collaboration with Transgene

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Nordic Life Science Insight

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Pfizer’s Xeljanz (tofacitinib) Fails to Meet its Co-Primary Endpoint in ORAL Surveillance Safety Study

Shots:

  • The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor
  • The primary analyses include 135 subjects with MACE and 164 subjects with malignancies. The results demonstrated the study failed to meet its co-primary endpoints i.e. non-inferiority of tofacitinib compared to TNFi in regard to MACE and malignancies (NMSC)
  • Pfizer is working with the US FDA and other regulatory agencies to review the full results and analyses as they become available.

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Pfizer

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Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

Shots:

  • The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO
  • Reduction in overall infections seen within 1st week with 100% prevention of symptomatic infections, 50% lower overall rates of infection and decreased peak virus levels and duration of viral shedding in asymptomatic infections
  • The confirmatory P-III results are expected early in Q2’21. REGEN-COV is being studied in two hospitalized patient trials and a P-III study for non-hospitalized patients

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: CNBC

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Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19

Shots:

  • The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting
  • The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements in all 2EPs including reductions in viral load and accelerated symptom resolution
  • The data from the BLAZE-1 study are both compelling and entirely consistent with the interim data that were the basis for EUA of bamlanivimab (700mg) in the US, Canada, and EU for mild to mod. COVID-19 in patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 or hospitalization

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Catalio Capital Management

The post Eli Lilly and AbCellera Report Results of Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV16) in P-II/III BLAZE-1 Study for Preventing COVID-19 first appeared on PharmaShots.

Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Shots:

  • The company presents the ongoing program of SARS-CoV-2 mutation surveillance for STI-2020 currently in pre/ clinical development for COVID-19
  • The data provides evidence of maintained binding potency in in vitro assays including the Spike amino acid changes found in SARS-CoV-2 viruses of the B.1.1.7 lineage, identified in the UK
  • Additional neutralizing Abs were identified that bind strongly to the B.1.1.7 & B.1.351 spike proteins and are under analyses for neutralization activities both in vitro and in vivo. Sorrento to unveils early in vitro results of diminished STI-2020 binding potency in assays including Spike proteins derived from viruses of the B.1.351 lineage, identified in SA

Click here ­to­ read full press release/ article | Ref: Sorrento | Image: Analyze Markets

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Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Shots:

  • The complete dose-finding part of P-Ib/II study assessed the safety, feasibility, and RP2D of NBTXR3 (intratumoral inj.) in 20 patients with LA (T3 to T4) or unresectable rectal cancer
  • The study showed ORR after CCRT in >70% patients, 90% patients underwent total mesorectal excision (surgery); 17.6% achieved pCR; 50% receiving surgery had good tumor regression; therapy was feasible and was well tolerated at all dose levels
  • Nbtxr3 is a novel, potentially first-in-class therapy designed to destroy tumors through physical cell death when activated by radiotherapy.

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Wikipedia

The post Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021 first appeared on PharmaShots.

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Shots:

  • The P-Ib/II study involves assessing of Onvansertib + Folfiri and bevacizumab in 44 patients with 2L treatment of KRAS-mutated mCRC. The company also provided an additional data update from its mCRC clinical program and initial findings from its EAP
  • Out of the 12 P-1b patients, 42% achieved PR & 67% have shown a durable response ranging from 6.1-13.7mos. The RP2D has been established at 15mg/m2 and the P-II segment of the ongoing trial is open to full enrollment of ~26 patients across 6 sites in the US
  • In the EAP, 66% of the initial 9 patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses lasting an avg. of 6 mos.

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Cardiff oncology

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GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Shots:

  • The ongoing P-I GARNET study involves assessing dostarlimab as monothx. in patients with advanced solid tumors. Cohort F of the GARNET trial enrolled patients with dMMR non-endometrial solid cancers in which patients received dostarlimab (500mg, q3w) for four doses and dostarlimab (1000mg, q6w) thereafter for ~2yrs. or until disease progression or discontinuation
  • The study demonstrated ORR (38.7%). Additionally, after a median follow-up of 12.4mos., mDoR had not yet been reached and responses were durable across tumor types
  • Dostarlimab is a PD-1 mAb targeting PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2 and is under review in the US and EU

Click here ­to­ read full press release/ article | Ref: GSK | Image: BBC

The post GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI first appeared on PharmaShots.

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Shots:

  • The P-II/III study involves assessing of CT-P59 (40mg/kg, 80mg/kg) vs PBO in 327 patients with mild-to-mod. symptoms of COVID-19
  • Results: reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); recovery days (5.4 vs 8.8 days); recovery time in patients with pneumonia & patients aged ≥50yrs. (5.7 vs 10.8 & 6.6 vs 13days) respectively. CT-P59 showed reduction in viral load @day7 with SAEs reported
  • The preclinical data demonstrated a 100-fold reduction in viral load of SARS-CoV-2 and improved recovery time in animal models, that has been published in Nature Communications journal

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Medicircle

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BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Shots:

  • The ongoing P-III GENEr8-1 study involves assessing of valoctocogene roxaparvovec (6e13 vg/kg dose) in 134 patients with with severe hemophilia A. The patients received a single dose of valoctocogene roxaparvovec and completed a year or more of follow-up
  • The study met 1EPs & 2EPs i.e. reduction in ABR by 84% demonstrating superiority to factor VIII prophylaxis and reduced mean annualized factor VIII infusion rate by 99%. In subset dosed >2yrs. ago, rate of decline in factor VIII expression is slow
  • Mean ABR in the population was 0.9 over these two-plus yrs. BioMarin plans to meet with EMA to discuss the submission of 1yrs. data and the FDA to review 2yrs. data-request

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Northbay Biz

The post BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A first appeared on PharmaShots.

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Shots:

  • The P-III ADVANCE & MOTIVATE studies involves assessing of Risankizumab (600/1200mg) vs PBO in adult patients with mod. to sev. CD who had an inadequate response/ were intolerant to conventional and/or biologic therapy & patients who had responded inadequately or were intolerant to biologic therapy respectively
  • Results: @12wks. clinical remission as per CDAI (45%/42% vs 25%) & (42%/41% vs 19%); clinical remission per PRO-2 (43%/41% vs 21%) & (35%/39% vs 19%); endoscopic response (40%/32% vs 12%) & (29%/34% vs 11%) respectively
  • Skyrizi is an IL-23 inhibitor, being evaluated in mod. to sev. CD and other immune-mediated conditions

Click here ­to­ read full press release/ article | Ref: AbbVie| Image: Law.com

The post AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease first appeared on PharmaShots.

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Shots:

  • The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy
  • The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait speed assessed by the timed 10-MWT respectively. Additionally, therapy showed improvements in the 9mos. exploratory cardiac endpoint of NT-proBNP
  • The company plans to submit NDA to the US FDA in H1’21, following the regulatory filing in Brazil and Japan. Moreover, Alnylam intends to submit MAA in the EU on obtaining the results of 18mos. analysis, anticipated in late 2021

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Bloomberg

The post Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy first appeared on PharmaShots.

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Shots:

  • The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively
  • Results: ACR20 (57% & 51% vs 34% & 27%); ACR50 (33% & 26% vs 11% & 9%); ACR70 (15% & 12% vs 5% & 6%); PASI 90 (52% & 55% vs 10% & 10%); HAQ-DI (-0.31 & -0.22 vs -0.11 & -0.05); MDA (25% & 26% vs 10% & 11%) respectively
  • The safety profile is consistent with the known profile of risankizumab in psoriasis patients. Skyrizi is an IL-23 inhibitor, being developed in collaboration with Boehringer Ingelheim

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Modern Healthcare

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RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Shots:

  • The P-II US study involves assessing Opaganib + SOC vs PBO + SOC in 40 patients requiring oxygen support in a ratio (1:1) and were followed up for ~42days post-treatment initiation
  • The study demonstrated improvement in reaching room air within 14days (52.6% vs 22.2%); improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs 55.6%), reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs 46.7%)
  • The results from the global P-II/III study in 270 hospitalized patients expected in Q1’21 and an interim DSMB futility analysis is expected in the coming weeks

Click here ­to­ read full press release/ article | Ref: Redhill Bio | Image: PR Newswire UK

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Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Shots:

  • The results of an interim analysis of P-III study showed that the safety of the new coronavirus inactivated vaccine after inoculation
  • All patients produced high-titer Abs, the neutralizing Ab positive conversion rate was 99.52% while vaccine efficacy was 79.34%
  • The vaccine has been granted authorization in several countries and has also been rolled out in part in China. The company is now seeking full approval in China

Click here ­to­ read full press release/ article | Ref: Sinopharm | Image: Sinopharm

The post Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study first appeared on PharmaShots.

AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma

Shots:

  • The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks.
  • The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma control, the safety profile was consistent with previous trials. The therapy’s other efficacy parameters were similar to those observed in previous trials, including the P-III NAVIGATOR trial
  • Tezepelumab is a human mAb targeting TSLP, being developed in collaboration with AstraZeneca and Amgen

Click here ­to­ read full press release/ article | Ref: AstraZeneca  | Image: Physicians Practice

The post AstraZeneca’s Tezepelumab Fails to Meet its Primary Endpoint in P-III SOURCE Study for Asthma first appeared on PharmaShots.

Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema

Shots:

  • The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) administered at personalized dosing intervals of ~16wks and at fixed 8wks. intervals & aflibercept (2mg) at fixed 8wks. intervals
  • The studies met its 1EPs i.e faricimab in both the doses demonstrated non-inferior visual acuity gains compared to aflibercept and was well tolerated with no new safety signals identified
  • Faricimab is the first investigational bispecific Ab targeting 2 distinct pathways i.e., Ang-2 and VEGF-A, currently being evaluated in P-III TENAYA and LUCERNE studies for nAMD

Click here ­to­ read full press release/ article | Ref: GlobeNewswire  | Image: Forbes

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Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Shots:

  • The P-lll RUXCOVID study involves assessing Ruxolitinib (5mg, bid) + SoC therapy vs PBO + SoC therapy in 432 patients aged ≥12 yrs. in a ratio (2:1) hospitalized for COVID-19 and not intubated or receiving ICU care prior to randomization
  • The study did not meet its 1EPS of reducing the number of hospitalized COVID-19 patients who experienced severe complications @29days (death, mechanical ventilation or ICU care i.e. (12% vs 11.8%). The trial did not show benefits among 2EPs and exploratory endpoints including mortality rate @Day29 and time to recovery
  • Ruxolitinib is an oral JAK 1 and JAK 2 tyrosine kinases inhibitor and is approved under the name Jakavi in EU and other countries for PV & MF

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Financial Times

The post Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19 first appeared on PharmaShots.

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Shots:

  • Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with MIUC, who are at high risk of recurrence following resection
  • Results: in people with ctDNA, DFS Median (5.9 vs 4.4 mos.); median OS (25.8 vs 15.8 mos.). As presented in ASCO, the study did not meet its 1EPs of DFS (19.4 vs 16.6 mos.) in IIT population
  • In general, people with MIUC who had detectable ctDNA were more likely to benefit from treatment with adjuvant Tecentriq monothx. compared with those without ctDNA

Click here ­to­ read full press release/ article | Ref: Roche | Image: Mint

The post Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020 first appeared on PharmaShots.

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Shots:

  • The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- m-BC
  • Result: @53.5 mos. follow-up, m-OS (58.7 vs 48.0 mos.); similar m-OS (58.7 vs 47.7 mos.) observed in IIT population; @ 42 mos. follow-up, estimated survival rate (70.2% vs 46%)
  • The US FDA and EC has approved Kisqali in Mar’2017 and Aug’2017 as initial endocrine-based therapy for postmenopausal women with HR+/HER2- LA/m-BC in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioProcess International

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Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Shots:

  • The P-lll SURPASS-1 study involves assessing Tirzepatide as monothx. (5/10/15 mg) vs PBO in 478 patients in the ratio of (1:1:1:1) with T2D inadequately controlled with diet and exercise alone
  • Results: A1C reduction: (-1.75% /-1.71%/-1.69% vs- 0.09%); Weight reduction: 6.3/7.0/7.8kg vs 1.0 kg; percentage of participants achieving A1C <7%: 81.8%/84.5%/ 78.3% vs 23.0%; percentage of participants achieving A1C <5.7%: 30.9% /26.8%/38.4% vs 1.4% respectively
  • The highest dose led to A1C reduction of 2.07 % with a reduction in body weight by 9.5 kg (11 %), 51.7 % of patients achieved an A1C less than 5.7 %

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Diario AS

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AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Shots:

  • The results of an interim of P-III program demonstrated that AZD1222 is safe & effective at preventing symptomatic COVID-19 and hospitalization. The interim analysis for efficacy was based on ~11,636 participants accruing 131 symptomatic infections from the P-III UK and Brazil trials
  • The 1EPs based on the pooling of two dosing regimens showed vaccine is 70.4% effective at preventing COVID-19 occur >14days after receiving 2 doses of the vaccine. 2EPs of prevention demonstrated no cases of severe infections in the vaccine group
  • A further analysis showed that vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose. Regulatory submissions are underway to support approval of vaccines

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: US News & World Report

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Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Shots:

  • The P-lll ASCEMBL study involves assessing Asciminib (40mg, bid) vs Bosulif (bosutinib, 500mg, qd) in 223 patients with Ph+ CML-CP prior treated with two or more TKIs and the data were presented at 62nd (ASH) Annual Meeting & Exposition
  • Results: @ 24 wks. MMR rate (25.5% vs 13.2%) tCCyR rate (40.8% vs 24.2%); DMR rate were higher with patients achieving MR4 and MR5(10.8% and 8.9% vs 5.3% and 1.3%); Grade ≥3 AEs (50.6% and 60.5%) respectively, presented at ASH
  • The US FDA has granted FT designation for Asciminib while the regulatory submission to the US and EU health authorities is planned for H1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PMLiVE

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Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Shots:

  • Nektar presents two nonclinical data presentations for NKTR-255 at the 62nd ASH Annual Meeting, which include an oral presentation of translational research studies conducted in collaboration with researchers from Dana-Farber Cancer Center
  • NKTR-255 is being tested in a P-Ib/II study as monothx. & in combination with rituximab or daratumumab in patients with MM & NHL and being evaluated in a P-Ib/II trial in combination with cetuximab for the treatment of colorectal cancer & HNSCC
  • NKTR-255 is an IL-15 receptor agonist designed to activate the IL-15 pathway & expand NK cell, promoting the survival & expansion of memory CD8+ T cells without inducing suppressive regulatory T cells

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Street

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Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Shots:

  • The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
  • Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
  • Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Cladding Corp

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Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Shots:

  • Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL
  • The data showed a reduction in the risk of disease progression or death by 81%, m-OS (82.1% vs 62.2%), patients who completed 2yrs. of treatment without the progressive disease, 63.8% had uMRD
  • The P-III CLL14 study also confirms the potential of MRD measurements to predict future outcomes for people with prior untreated CLL who were treated with fixed-duration Venclexta/Venclyxto + Gazyva/Gazyvaro vs Gazyva/Gazyvaro + chlorambucil

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fierce Pharma

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Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma

Shots:

  • The P-II ZUMA-5 study involves assessing Yescarta (axicabtagene ciloleucel) in patients with r/r iNHL after at least 2L of systemic therapy. After a single infusion of Yescarta, 92% of patients responded, including 76% of patients achieving a CR @median follow-up of 17.5 mos., results presented at ASH
  • The data supports the US FDA’s acceptance of BLA and is currently under PR for r/r FL, MZL, after two or more prior lines of systemic therapy, with an anticipated PDUFA date as Mar 5, 2021
  • Yescarta is the first CAR T-cell therapy to be approved by the US FDA for patients with r/r large B-cell lymphoma after two or more lines of systemic therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Seek Vector Logo

The post Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin lymphoma first appeared on PharmaShots.

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Shots:

  • Janssen reported pooled analyses of long-term follow-up from multiple clinical trials evaluating the use of Imbruvica monothx. and in combination as a 1L treatment for patients with CLL with high-risk features
  • Results from an integrated analysis of two clinical trials with ~79mos. of follow-up demonstrated PFS rates (63%-82%) @42mos.; median duration of treatment across high-risk subgroups (35.7-43.8 mos.)
  • Additionally, data with a median follow-up of >4yrs. were presented from a pooled analysis of 89 patients with high-risk CLL bearing TP53 aberrations from 4 trials. Further, data from the RWE studies highlight the benefit of ibrutinib-based therapies in a 1L setting

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: LBC

The post Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia first appeared on PharmaShots.

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Shots:

  • The P-III ATLANTIS study involves assessing Zepzelca (lurbinectedin, 2.0mg/m2) + doxorubicin vs topotecan/ CAV in 613 adult patients in a ratio (1:1) aged ≥18yrs. with SCLC whose disease progressed following one prior Pt.-containing line
  • The study did not meet its 1EP of OS in the ITT population while there were no adverse effects on OS with the experimental arm. The safety data were consistent with the known safety profile of Zepzelca monothx. with no new safety signals observed
  • Zepzelca is an alkylating drug that binds guanine residues within DNA. The therapy received the US FDA’s accelerated approval in Jun’2020 for m-SCLC with disease progression on or after Pt.-based CT

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: WebMD

The post Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC first appeared on PharmaShots.

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Shots:

  • AstraZeneca will divulge new developments across BC at the 2020 SABCS. The key abstract includes data of P-ll DESTINY-Breast01 study reinforcing the efficacy seen with Enhertu in HER2+ mBC following 2+ prior anti-HER2 based regimens
  • The company will present data of P-I SERENA-1 study demonstrating the efficacy & safety of AZD9833 as a monothx. and in combination with the palbociclib in HR+, HER2- negative advanced BC
  • AstraZeneca will present RWE to understand outcomes for patients with germline BRCA mutations and treatment patterns among patients with HER2+ mBC. The company will also showcase data on the role of AI & digital pathology in measuring levels of HER2 expression in patients with BC

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Stat

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Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Shots:

  • The P-IIa study involves assessing vibegron (75mg,qd) in 222 women with abdominal pain due to IBS with IBS-D (diarrhea) and IBS-M (mixed IBS) across 35 sites in the US
  • The study did not meet its 1EPs i.e. at least a 30 percent improvement in average worst abdominal pain @12wks. ( 40.9% vs 42.9%), well tolerated and did not lead to worsening of IBS symptoms
  • Vibegron is (PO,qd) is a beta-3 agonist that is being evaluated for OAB, OAB+BPH in men & for abdominal pain associated with IBS

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Urovant

The post Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain first appeared on PharmaShots.

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Shots:

  • The ongoing P-lll study involves assessing of Sputnik V vaccine vs PBO in 40,000 patients in a ratio (1:3) with COVID-19. The efficacy of the vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose
  • Preliminary data from volunteers obtained 42days after the first dose (corresponds with 21days after the second dose) indicates the efficacy of the vaccine above 95%.
  • The data will be published by the Gamaleya Center team in peer-reviewed medical journals. Following the completion of P-lll clinical trials, Gamaleya Center will provide access to the full clinical trial report

Click here ­to­ read full press release/ article | Ref: Sputnik | Image: Anadolu Agency

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Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Shots:

  • The exploratory P-l/ll study involves the assessment of ONCOS-102 + SoC CT (pemetrexed/cisplatin) as a 1L and 2L treatment in 31 patients with MPM
  • Result: @18mos. follow up showed that mOS (18.2mos. vs 14.2mos.) and showed broad and powerful immune activation, associated with better survival outcome. The next survival analysis is planned in H1’21
  • Targovax and Merck are currently reviewing the next steps for combining ONCOS-102 and Keytruda in MPM

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Targovax

The post Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma first appeared on PharmaShots.

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots:

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NBC News

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Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Shots:

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Pharma Letter

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ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Shots:

  • In the PROgress study, 200 people living with HIV were provided with a pre-visit survey to guide their conversation with their HCP and assess PROs covering a range of measures, including treatment adherence, mental health, substance abuse, and intimate partner violence
  • Results: the inclusion of the pre-visit survey made their visit better overall (82%), reminded them of health concerns to raise (81%), and helped them discuss issues that were difficult to speak frankly about (71%).
  • The PROgress study program released an implementation toolkit and resources to assist HCPs with the adoption of PROs into their clinical practices

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

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Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Shots:

  • The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged > 18 yrs. in the US
  • The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis of the P-III COVE study. The first interim analysis included 95 participants with confirmed cases of COVID-19
  • Moderna plans to submit a EUA with US FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of >2mos.

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Stat

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AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Shots:

  • The P-ll CALAVI programme involves assessing Calquence + BSC vs BSC as monothx. in patients in a ratio (1:1) hospitalized with respiratory complications of COVID-19 in the ratio of 1:1. The trials conducted in the US and in multiple other countries across the world
  • The CALAVI program did not meet its 1EPs of increasing the proportion of patients who remained alive and free of respiratory failure, safety and tolerability profiles were consistent with previous studies
  • Calquence is selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity

Click here­ to­ read full press release/ article | Ref: AstraZeneca | Image: Red River Radio

The post AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19 first appeared on PharmaShots.

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Shots:

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

Click here­ to­ read full press release/ article | Ref: Pfizer | Image: Forbes

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Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Shots:

  • The expansion cohort of P-l study involves assessing of mRNA-4157 + Keytruda (pembrolizumab) vs Keytruda monothx. in 10 patients with HPV (-) HNSCC and 17 patients with MSS-CRC, presented at the SITC 2020.
  • Results: in the HPV(-) HNSCC group, ORR (50% vs 14.6%) with 2 patients achieving CR & 3 patients achieving PR; mPFS (9.8 vs 2.0 mos.); DCR (90%); median duration of response has not been reached. No responses were observed in the MSS-CRC group of patients
  • The company continues to recruit in HPV(-) HNSCC cohort and has decided to expand the size of the current cohort based on the interim data reported

Click here­ to­ read full press release/ article | Ref: Businesswire | Image: Stat

The post Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC first appeared on PharmaShots.

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Shots:

  • The P-l study involves assessing CVnCoV in patients with COVID-19. The interim data showed that CVnCoV (2-12µg) was well tolerated and induced strong binding and neutralizing Ab responses to the first indication of T cell activation
  • The immune response was found to be comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The manuscript is available on medRxiv and will be submitted for publication in a peer-reviewed journal
  • The P-l clinical study began in June 2020 in Germany and Belgium in collaboration with the CEPI. CureVac plans to initiate a pivotal P-IIb/III clinical study by the end of 2020

Click here ­to­ read full press release/ article | Ref: CureVac | Image: CNN

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AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots:

  • The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS
  • Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall population. The study also met 1EPs in patients with low levels of eosinophils i.e. <300 & 150 cells/microlitre
  • Tezepelumab is mAb that inhibits the action of TSLP and has received US FDA’s BT designation in Sept’2018 for patients with severe asthma, without an eosinophilic phenotype

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

The post AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma first appeared on PharmaShots.

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Shots:

  • The P-lll CAN-COVID trial involves assessing Ilaris (canakinumab) + SOC vs PBO + SoC in 454 patients aged 18-98yrs. with COVID-19 pneumonia and cytokine release syndrome CRS, with its expected full results in early 2021
  • Result: The trial fails to meet its 1EPs of survival without the need for mechanical ventilation up to day29 (88.8% vs 85.7%) and did not meet its 2EPs of COVID-19-related mortality up to 4 wks. (4.9% vs 7.2%)
  • Canakinumab is mAb that binds to and neutralizes (IL-1β), blocking its action. Additionally, P-III trial for ruxolitinib in COVID-19 is ongoing, with preliminary results expected by end of 2020

Click here ­to­ read full press release/ article | Ref: Novartis | Image: US News Health

The post Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS first appeared on PharmaShots.

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Shots:

  • The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
  • Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
  • Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Medical News Today

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Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Shots:

  • The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted
  • In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold for non-inferiority; Grade 2/ any ≥ Grade 3 TEAEs (82.8% vs 79.6%); discontinuation (32.4% vs 26.8%); dose interruption (74.6% vs 83.3%); dose reductions (67.6% vs 69.6%)
  • Overall ORR (34.6% vs 40.6%); mPFS (11.1 vs 14.7mos.); m-OS (27.0 vs NE). Results were presented at IKCS 2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Welwyn Hatfield Times

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AZ’s Q3 results disappoint – but COVID19 vaccine trial is still on track

AstraZeneca has posted an uninspiring set of quarterly results as it gears up for results from its closely watched coronavirus vaccine trial.

AZ said in its third quarter results statement that it is on track to meet its guidance for the year, with total revenue expected to grow by 8%-12% and core earnings per share increasing by 15%-19%.

In the three months to the end of September AZ’s revenue increased by 3% to $6.6 billion, with products sales up 6%.

Earnings per share fell to $0.94, missing analysts’ estimates of $1, as some patients held off treatments for ailments unrelated to COVID-19.

AZ has pursued a strategy of selling off its older or unwanted drugs and has been benefiting from “collaboration revenue” from these deals as development partners reach certain milestones.

This revenue fell by 79% to $58 million compared with the same quarter last year, although the company said that this was down to a strong performance in last year’s Q3.

The company suggested that collaboration revenue may be higher in the next quarter as this income tends to come in chunks as various research projects reach fruition or sales targets are met.

At the same time the company also grabbed two new European approvals – for Lynparza in castration-resistant prostate cancer and for Forxiga for a form chronic heart failure.

The company’s coronavirus vaccine is perhaps the company’s most eagerly-watched pipeline asset, although AZ is unlikely to make much money from it – at least until the worst of the pandemic is over.

As reported by pharmaphorum earlier this week, AZ expects results from its late-stage trial by the end of the year despite a safety scare in September, setting up approval by regulators early in 2021.

AZ has pledged to sell the vaccine at cost price until a cut-off point expected midway through next year.

But as the UK heads for another economically damaging month-long lockdown the company confirmed that it could have crucial phase 3 data from the vaccine by the end of the year.

If approved the vaccine will do little for the company’s figures but will create huge goodwill as governments across the world seek an end to the spiral of death caused by the coronavirus.

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Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Shots:

  • The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA
  • The study reduction of synovitis @12wks. with an early improvement observed as 1wk., ACR20 (68% vs 34%); ACR50 (46% vs 9%,) & enthesitis (change in SPARCC, -2.4 vs -1.7); safety profile was consistent with previous studies @12wks.
  • Cosentyx is the first & only fully-human biologic that directly inhibits IL-17A. Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the EULAR in 2021 and final analysis at ACR 2021

Click here to­ read the full press release/ article | Ref: Novartis | Image: GMP News

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Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Shots:

  • The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer
  • The 1st study involves assessing of sintilimab + bevacizumab biosimilar vs sorafenib as 1L treatment for aHCC while the 2nd study includes assessing of sintilimab + anlotinib as 1L therapy in patients with aHCC. The 3rd study evaluates sintilimab + docetaxel in patients with previously treated advanced NSCLC while the 4th study evaluates autologous CIK cell immunotherapy + sintilimab + CT in patients with advanced NSCLC
  • 5th study includes assessing of neoadjuvant sintilimab + triplet CT for resectable ESCC, 6th study assesses sintilimab + FLOT regimen for neoadjuvant treatment of GEJ adenocarcinoma while 7th study assesses perioperative sintilimab + concurrent CRT for LA gastric or GEJ adenocarcinoma

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Fortune

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BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Shots:

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Fierce Biotech

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Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots:

  • The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC
  • The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while the median duration of follow-up was 34.6 mos.
  • Kisqali is a selective cyclin-dependent kinase inhibitor, acts by inhibiting two proteins called CDK4/6

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Law

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Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Shots:

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Brand Branders

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Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Shots:

  • The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG repeats in the FMR1 gene
  • The study demonstrated benefits in oral reading recognition (+2.80), picture vocabulary (+5.79), cognition crystallized composite score (+5.29), benefits were maintained up to 12wks. and was well tolerated
  • BPN14770 is a novel therapy that selectively inhibits PDE4D to increase the levels of cAMP. In preclinical trials, it promotes the maturation of connections between neurons, which is impaired in patients with FXS and has received the US FDA’s ODD as well as approved for investigational use in the US

Click here to­ read the full press release/ article | Ref: Businesswire | Image: Tetra Therapeutics

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Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Shots:

  • Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious AEs in the study during the open-label extension during which all patients received active treatment
  • Regeneron shared the update with the trial’s IDMC and regulatory authorities and will conduct a review of the study to better understand the benefit/risk profile of garetosmab in people with FOP
  • Garetosmab is a VelocImmune-derived mAb that binds and neutralizes Activin A, which is involved in the development of heterotopic bone in people with FOP

Click here to­ read the full press release/ article | Ref: Regeneron | Image: The Print

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UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Shots:

  • The P-III BE SURE study involves assessing bimekizumab vs Humira (adalimumab) for 24wks. is followed until 56wks. in 478 adult patients with chronic PsO for at least 6 mos. before screening & with an affected body surface area of at least 10%, PASI of at least 12 & IGA score equal to or > 3 on a 5point scale
  • Results: The study met its 1EPs & 2EPs, @16wks. PASI 90 (86.2% vs 47.2%); IGA 0/1 (85.3 % vs 57.2%); PASI 100 (60.8% vs 23.9%); PASI 100 @24wks. (66.8% vs 29.6%); PASI 90, PASI 100 and IGA 0/1 response rates were maintained through 1year with both q4w & q8w; skin clearance rates increased in patients who switched from adalimumab to bimekizumab @24wks., with response rates @56wks. comparable to patients treated with bimekizumab throughout the study
  • Bimekizumab is an investigational humanized IgG1 mAb that selectively inhibits both IL-17A & IL-17F

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Pharma Journalist

The post UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis first appeared on PharmaShots.

AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Shots:

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Seeking Alpha

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AstraZenca Reports Results of Fasenra (benralizumab) in P-lllb PONENTE Trial for Asthma

Shots:

  • It is based on P-lllb PONENTE trial assessing Fasenra (benralizumab, 30mg) in adult patients with severe Asthma on high-dose ICS + LABA and long-term use of OCS therapy with or without additional asthma controller. This study included approx. 600 patients in EU, North America, South America, and Taiwan
  • Results: 62% of patients achieved complete elimination of daily OCS use on 1EP and on the 2EP, 81% of patients achieved complete elimination or were able to reduce their daily OCS dose to 5mg or less when further reduction was not possible due to adrenal insufficiency
  • Fasenra is mAb that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis. It is currently approved as an add-on maintenance treatment for severe eosinophilic asthma and is approved for self-administration in the US, EU and other countries

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Fox News

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Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots:

  • The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion
  • Results: The study showed that bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19
  • LY-CoV555 is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2 & designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing & treating COVID-19

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

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Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Shots:

  • The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting
  • The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2
  • REGN-COV2 is a combination of two mAbs (REGN10933 + REGN10987), designed specifically to block the infectivity of SARS-CoV-2. Additionally, Regeneron has shared results with the US FDA, which is reviewing a EUA submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes

Click here to­ read full press release/ article | Ref: PRNewswire | Image: MediCircle

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Dermavant Presents Results of Tapinarof in Pivotal P-III PSOARING Program at the 29th EADV Virtual Congress

Shots:

  • The pivotal P-III clinical program for tapinarof in adult with PsO consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) PSOARING 3 (NCT04053387), an ongoing long-term safety study. Positive results of P-III studies were reported in Aug’2020
  • Tapinarof previously met the 1EP in separate P-IIb trials for PsO & AD, both studies were published in JAAD. The company anticipates its NDA filling in 2021
  • Tapinarof (qd) is a steroid-free, cosmetically elegant, TAMA topical cream being developed for the treatment of PsO and AD. To date, 2200+ subjects have enrolled in 18 clinical trials of tapinarof

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Dermavant

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AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study

Shots:

  • The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries
  • The study demonstrated that Forxiga achieved a significant reduction in the composite EP of hHF or CV death. The trial confirmed the well-established safety profile of Forxiga
  • The NMPA’s label update follows the update to the EU MAA in Aug’2019 and the US FDA’s approval granted in Oct’2019

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

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Sanofi Presents Results of Olipudase Alfa in Two Clinical Studies at ASHG 2020

Shots:

  • The P-II/III ASCEND trial involves assessing olipudase alfa 3 mg/kg (IV, q2w) vs PBO in 36 adult patients with ASMD type B to evaluate treatment impact on pulmonary function & spleen & liver volume for 52wks. The study demonstrated improvement in lung function (22% vs 3%), reduction in spleen volume (39.5% vs 0.5%), reduction in liver volume (31.7% vs 1.4%); improvement in platelet counts (16.8% vs 2.5%)
  • The P-II ASCEND-Peds trial involves assessing olipudase alfa 3 mg/kg (IV) q2w for 64 wks, in 20 pediatric patients with ASMD without acute or rapidly progressive neurological abnormalities. The study demonstrated 33% increment in predicted DLCO, reduction in spleen volume & liver volume (49% & 41%); 34% increment in platelet count
  • Olipudase alfa is an investigational enzyme replacement therapy designed to replace deficient or defective ASM, allowing for the breakdown of sphingomyelin, currently being investigated to treat non-CNS manifestations of ASMD. The therapy has received FDA’s BT designation, EMA’s PRIME Designation and MHLW’s SAKIGAKE designation

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Evaluate Pharma

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Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

Shots:

  • Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020
  • Results: Patients reported significant improvement on DSQ as 4 wks. and continued to improve through 24 wks; reduced EEC (<15) eos/hpf (64% vs 8%) @24wks. Peak EEC (71% vs 3%). ET changes associated with the disease reduced (0.761 and 0.753 vs 0.001 and 0.012) reduction @24wks.; gene expression patterns associated with type 2 inflammation and EoE were reduced (1.97-fold & 2.66-fold vs 0.32-fold & 0.16-fold); SAEs (86% vs 82%)
  • Dupixent is mAb inhibiting the signaling of the IL-4 and IL-13 proteins and has received the US FDA’s BT designation for the treatment of patients ≥12yrs. with EoE

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Chemistry World

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Samsung Bioepis Reports Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Shots:

  • The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020
  • One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis in patients with IBD identified from the VAHS database and demonstrated an 83% continuation rate over 1yr. with similar continuation rate in patients who underwent a single & double switch from reference infliximab
  • Second study focused on the real-world utilization pattern of infliximab products for IBD, within the context of VANF policy. The study found that Renflexis became the preferred infliximab product on VANF in Sept’2018 which was faster than the adoption of the previous biosimilar (infliximab-dyyb), listed on VANF in May’2017

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: The Investor

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Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

Shots:

  • The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020
  • In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was like the well-established safety profile of Jardiance. In Mar’2020, the US FDA granted FT designation to the therapy for CKD based on its ongoing EMPA-KIDNEY study with its expected results in 2022
  • In 2019, the US FDA granted FT designation to Jardiance for the reduction of the risk of CV death and hospitalization for heart failure in people with HF based on its EMPEROR program, which consists of two P-III studies EMPEROR-Reduced & EMPEROR-Preserved

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Dialysis Patient Citizens Education Center

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Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Shots:

  • The global program includes two P-III studies assessing vadadustat (PO) vs darbepoetin alfa (inj.) in a ratio (1:1) in incident dialysis patients (Correction/Conversion) and prevalent dialysis patients (Conversion), in ~3,923 adult patients on dialysis with anemia due to CKD
  • The presentation expands on previously reported positive data showing vadadustat achieved clear and consistent results across 1EPs & 2EPs
  • Vadadustat is an oral HIF-PH inhibitor designed to mimic the physiologic effect of altitude on oxygen availability and is also being evaluated in P-III PRO2TECT for anemia due to CKD in adult patients, not on dialysis. The company plans to submit NDA to the US FDA for anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients in 2021

Click here ­to­ read full press release/ article | Ref: Akebia | Image: Akebia

The post Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week first appeared on PharmaShots.

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

Shots:

  • The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses
  • Sanifit also presents the design of its ongoing P-III CALCIPHYX study evaluating the efficacy and safety of SNF472 for the treatment of patients with calciphylaxis (calcific uremic arteriolopathy, or CUA). Additional data demonstrated that SNF472 strongly inhibits valvular calcification in an in vitro model of porcine aortic valve
  • SNF472 is an inhibitor of vascular calcification currently in P-III study, acts by targeting the deposition of solid calcium (hydroxyapatite, HAP) in the CV system. The company is showcasing new data on SNF472 in four presentations including one oral session and three ePoster sessions at virtual ASN Kidney Week 2020

Click here ­to­ read full press release/ article | Ref: Sanifit | Image: European Biotechnology

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GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Shots:

  • The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy
  • Results: study met its 1EPs & 2EPs i.e. differences in median change in a weekly number of cataplexy attacks and ESS scores. Results were published at World Sleep 2019
  • Xywav is an oxybate product with a unique composition of cations resulting in 92% less sodium or ~1,000- 1,500 mg/night less than sodium oxybate at the recommended dosage range of 6-9gms. The company expects to launch in Q4’20, following RESM implementation

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: GMP News

The post Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy first appeared on PharmaShots.

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots:

  • AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent
  • The sNDA is based on the P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO for 3yrs. or until disease recurrence in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumour resection & adjuvant CT as indicated. Unprecedented results showed reduction in the risk of disease recurrence or death by 80% and improvement in DFS
  • Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases with its expected PDUFA date in Q1’21

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Print

The post AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer first appeared on PharmaShots.

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Shots:

  • The P-II ROCCELLA is a dose-ranging trial involves assessing GLPG1972/S201086 (PO, qd) in three different doses vs PBO in 932 patients with knee OA for 52wks. across 12 countries including EU, Asia, North and South America. Galapagos is responsible for ROCCELLA in the US, where 326 patients were recruited while Servier will be solely responsible for trial in 11 countries where 606 patients were recruited
  • The trial failed to meet its 1EPs as the change from baseline to 52 in cartilage thickness in mm (SD) is {-0.068 (0.20), -0.097 (0.27) & -0.085 (0.22)} vs -0.116 (0.27) for the low, medium & high dose respectively
  • No difference in 2EPS including clinical outcomes, the therapy was generally well-tolerated by patients in the P-II study

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Servier

The post Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis first appeared on PharmaShots.

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Shots:

  • The P-III CHRONOS-3 study involves assessing of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing treatment
  • The P-II study met its 1EP of prolonged PFS, safety is consistent with previously published data on the individual components of the combination, no new safety signals were identified
  • Aliqopa is a PI3K inhibitor with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells and is an approved treatment for patients with relapsed FL prior treated with two systemic therapies

    Click here to­ read the full press release/ article | Ref: Businesswire Image: Business Insider

The post Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma first appeared on PharmaShots.

Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure

Shots:

  • The P-lll GALACTIC-HF study involves the assessing of Omecamtiv mecarbil (25mg, bid with the maintenance dose of 50 mg, 37.5mg, or 25mg, bid) vs PBO in 8,256 patients with HFrEF
  • Result: The study met its 1EPs of reduction in CV death or HF events (HF hospitalization and other urgent treatment for HF) while the study did not meet its 2EPs of reduction in time to CV death, presented at AHA 2020
  • Omecamtiv mecarbil is a cardiac myosin activator, targeting the contractile mechanisms of the heart, being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

    Click here ­to­ read full press release/ article | Ref: Amgen | Image: The Times

The post Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure first appeared on PharmaShots.

BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer

Shots:

  • The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC
  • The study met its 1EPs of improved pathologic complete response. The positive results marks the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy as neoadjuvant therapy in a P-III trial in resectable NSCLC
  • The study is ongoing to assess other 1EPsof EFS. Opdivo-based treatments demonstrated benefit in 4 P-III clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma

Click here ­to­ read full press release/ article | Ref: BMS | Image: BMS

The post BMS Report Results of Opdivo (nivolumab) + CT in P-III CheckMate-816 Trial for Resectable Non-Small Cell Lung Cancer first appeared on PharmaShots.

Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1

Shots:  

  • The P-III STR1VE-EU study involves assessing Zolgensma (IV) in patients with SMA Type 1 aged <6mos. at the time of gene therapy, with 1 or 2 copies of the SMN2 backup gene and have bi-allelic SMN1 gene deletion or point mutations
  • Results: 65.6% achieved motor milestones not observed in the natural history of SMA Type 1, 66.7% were free of feeding support, 93.9% are able to swallow thin liquids, 30.3% required feeding support, 27.3% required ventilatory support; 97% patients in ITT population survived event-free, including 93.8% & 56.3% who could have reached 10.5mos. & 13.6 mos. of age respectively
  • New interim P-III STR1VE-EU data presented at WMS support the clinical evidence demonstrating a consistent, transformative benefit across Zolgensma clinical trials for the treatment of patients with SMA

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Mint

Related News: Novartis’ Zolgensma (onasemnogene abeparvovec) Receives MHLW’s Approval for Spinal Muscular Atrophy

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Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Shots: 

  • The P-II COMPARE study assessing SEL-212 (once monthly) vs pegloticase (twice monthly) in 170 patients with chronic refractory gout
  • SEL-212 showed a numerically higher response rate on 1EP during 3 & 6 mos., but didn’t meet 1EP of superiority, higher response rate during 3 & 6mos., an overall reduction in mean SUA levels; patients with tophi at baseline showed higher responder rates with a reduction in mean SUA and is well tolerated
  • SEL-212 is a combination product candidate designed to sustain control SUA levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits. The companies also initiate the P-III studies (DISSOLVE I& II) of SEL-212 for chronic refractory gout with its expected results in H2’22 and BLA filing in Q3’23

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Mynewsdesk

The post Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout first appeared on PharmaShots.

Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Shots:

  • The P-III ILLUMINATE-B study involves assessing Lumasiran in 18 patients with PH1 under the age of 6 (3-72mos.), with an eGFR >45 mL/min/1.73 m2 or normal serum creatinine if less than 12mos. old at 9 study sites in 5 countries across the globe
  • The study demonstrated a reduction in the hepatic production of oxalate across all ages, safety & tolerability profile is consistent with that observed in P-III ILLUMINATE-A study. The study also demonstrated positive results across 2EPs, including additional measures of urinary and plasma oxalate
  • Lumasiran (SC) RNAi therapeutic targeting HAO1 in development for the treatment of PH1 and has received the US FDA’s ODD & BT in addition to EMA’s ODD and PRIME designation

Click here ­to­ read full press release/ article | Ref: Alnylam | Image: Alnylam

The post Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six first appeared on PharmaShots.

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Shots:

  • The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs
  • The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks.
  • Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP), being evaluated in multiple clinical studies addressing the needs of CML patients. The US FDA has granted FT designation for the therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Fortune

Takeda and Ovid Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Shots:

  • The P-II ELEKTRA study involves assessing of soticlestat vs PBO in pediatric patients, aged 2-17 yrs., with highly refractory epileptic seizures associated with DS (convulsive seizures) or LGS (drop seizures)
  • Results: meeting its 1EPs i.e. reduction in DS & LGS (27.8% vs 3.1% & 29.8% vs 0.0%) during the 12-wks. maintenance period & 20-wks. treatment period (titration plus maintenance) respectively. In DS cohort, reduction in convulsive seizure (33.8% vs 7.0%) during the full 20-week treatment period, following which companies are planning to initiate P-III program
  • In the LGS cohort, reduction in drop seizure frequency (20.6% vs 6.0%) during the full 20-week treatment period of the study. Soticlestat is a potent, highly selective, oral, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H)

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Northcott

Fitbit Report Results of its COVID-19 Study for Early Detection of Diseases

Shots:

  • In May’2020, Fitbit has launched its COVID-19 study to build an algorithm that detects COVID-19 before symptoms starts. The study has enrolled 1000+ positive patients across the US and Canada is now delivering its first, preliminary results 90 days later
  • The study demonstrated that its devices could detect ~50% of COVID-19 cases one day before participants reported the onset of symptoms such as fever, cough, or muscle aches
  • The algorithm is under development and worked with 70% specificity, or a 30% rate of false positives. The study reinforces that breathing rate, resting heart rate and HRV are all useful metrics for indicating onset of illness and are best tracked at night, when the body is at rest

Click here ­to­ read full press release/ article | Ref: Fibit | Image: Bloomberg

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots:

  • The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites 
  • Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR (0.11 vs 0.22 & 0.10 vs 0.25); reduction Gd+T1 lesions (97% & 94%); reduction in new or enlarging T2 lesions (82% & 85%); superior in reducing neuroaxonal damage in both studies, as measured by NfL serum concentrations; 34% and 32% risk reduction in 3mos. and 6mos. CDW; favorable trend in rate of 6mos. CDI; no difference in annual rate of brain volume loss
  • Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its anticipated US FDA’s approval in Sept’20 and in EU by Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Clinical Trial Arena

Related News: The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis




Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots:

  • The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally
  • At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the US FDA in 2021, and then in EU, while the results will be presented at an upcoming medical meeting
  • Kymriah has received FDA’s RMAT designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for FL. The Therapy was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania

Click here to­ read full press release/ article | Ref: Novartis | Image: Behance

Related News: Novartis’ Kymriah Receives NICE Approval for R/R Diffuse Large B-cell lymphoma (DLBCL) in Adults




Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Shots:

  • The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively
  • The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall safety profile was similar. Additionally, the full data of the stay will be presented at ESC 2020 on Aug 29, 2020, with expected regulatory submissions are planned in 2020
  • Jardiance is a prescribed drug administered along with diet and exercise to lower blood sugar in and helps in reduction of CV death in adults with T2D

Click here to read full press release/ article | Ref: Eli Lilly | Image: Pharma World




AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Shots:

  • The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks.
  • Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% vs 11%); Improvement in Worst Pruritus NRS≥4 (52%/64% vs 15%)’ high TCS-freedays
  • Rinvoq (qd) is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases and has received the US FDA’s approval for patients with mod. to sev. active RA having inadequate response or intolerance to MTX. The therapy is under P-III study for AD, RA, PsA, axSpA, CD, UC, and giant cell arteritis

Click here ­to­ read full press release/ article | Ref: AbbVie | Image: Chicago SunTimes




AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots:

  • The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D
  • The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the onset of ESKD and death from CV/ renal cause) and 2EPs i.e. time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD, and renal death
  • Farxiga (PO, qd) is an SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monothx. and combination therapy as an adjunct to diet and exercise to improve glycemic control, weight loss and BP reduction

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Bloomberg Quint




Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots:

  • The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy
  • Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, monthly IVT), PDS demonstrated non-inferior and equivalent visual acuity outcomes with a favorable benefit-risk profile
  • PDS is a permanent refillable eye implant that continuously delivers a customized formulation of ranibizumab over a period of mos., potentially reducing the treatment burden associated with frequent eye injections

Click here to read full press release/ article | Ref: Genentech | Image: Twitter




Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Shots:

  • The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19
  • Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of the virus. 2EPs include 40% faster achievement of clinical cure, patients receiving clinical cure @day4 (69.8% vs 44.9%) median time to first-time use of oxygen in clinically deteriorated (5days vs 2days)
  • on June 20, 2020, FabiFlu has received DCGI’s approval, making it the first oral approved medication in India for the treatment of mild to moderate COVID-19. Glenmark has initiated PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 patients

Click here to read full press release/ article | Ref: Glenmark | Image: IndiaTVNews

Related News: Glenmark Launches FabiFlu (favipiravir) as the First Oral Medication to Treat Mild to Moderate COVID-19 in India




AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Shots:

  • The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks.
  • The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs 13%), patient achieving vIGA-AD 0/1 (39%/52% vs 5%); reduction in itch (42%/60% vs 9%); Improvement in Worst Pruritus NRS≥4 (42%/60% vs 9%) respectively
  • Rinvoq (qd) is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases and has received the US FDA’s approval for patients with mod. to sev. active RA having inadequate response or intolerance to MTX. The therapy is under P-III study for AD, RA, PsA, axSpA, CD, UC and giant cell arteritis

Click here to read full press release/ article | Ref: PRNewswire | Image: WSJ




Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots:

  • The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg secukinumab @ 0, 1, 2, 3, 4wks. followed by 300mg, q4w starting @4wks.; PBO @ 0, 4, 8, 12 wks. followed by 250mg mirikizumab q4w starting @16wks. through 32wks. followed by q8w thereafter
  • Results: @16wks. sPGA(0,1) (79.7% vs 6.3% & 76.3%), PASI 90 (74.4% vs 6.3% & 72.8%); PASI 100 (37.7% vs 1.8% & 36.6%). In general, the study resulted in meeting its 1EPs and all key 2EPs vs PBO @16wks. and all key 2EPs vs Cosentyx (secukinumab) @16wks. (non-inferiority) and @52wks. (superiority)
  • Mirikizumab is an IgG4 mAb binding p19 subunit of IL-23 and being evaluated for immune diseases, including psoriasis, UC and CD

Click here to read full press release/ article | Ref: Eli Lilly | Image: Glassdoor




AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Shots:

  • The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days
  • Results: 17% reduction in 1EPs of stroke and death, 21% reduction in 2EPs of ischaemic stroke, the risk for severe bleeding events (0.1% vs 0.5%); results were consistent with the known safety profile of Brilinta
  • Brilinta is approved in 110+ countries to prevent atherothrombotic events in adult patients with ACS and in 70+ countries for the secondary prevention of CV events among high-risk patients experienced a heart attack. In May’2020, the FDA approved a label update for Brilinta in the US to include the reduction of the risk of a first heart attack or stroke in high-risk patients with CAD

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: CNBC




Eisai Reports Results of DAYVIGO (lemborexant) in P-III SUNRISE 1 Study in Patients with Insomnia Disorder

Shots:

  • The P-III SUNRISE 1 (Study 304) study involves assessing of DAYVIGO (lemborexant, 5 or 10 mg) vs an active comparator or PBO in 1,006 patients with insomnia disorder aged 55 years of age or older
  • Results of P-III [email protected] 5/10 mg of DAYVIGO: headache (6.4%, 4.9 % vs 6.2%, 5.3%), somnolence (4.1%, 7.1% vs 1.9%, 1.5%), published in JAMA Network Open
  • Lemborexant is a candidate targeted for inhibiting orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2) and has also received the US FDA’s approval on Dec 20 , 2019 for patients to treat insomnia and will be available in 90 days post-approval

Click here to read full press release/ article | Ref: PRNewswire | Image: Behance