Category: results
As a result of the partnership, clinicians using Epic will be able to order Foundation Medicine’s genomic profiling tests directly from the EHR and view results in the system, providing them with clinical decision support.
Shots: The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis The SB11 is […]
Shots: The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season The study met its 1EPs i.e. reduction of LRTI due to RSV […]
Shots: The two P-III PSOARING 1 and PSOARING 2 trials involve evaluating Tapinarof (1% dosed, qd) vs vehicle (qd) in 1,025 patients aged 18-75yrs. with plaque psoriasis Results: 2EPs & PRO, @12wks., PASI90 (18.8% and 20.9%) vs (1.6% and 2.5%), ≥4-point NRS improvement (67.5% and 59.7%) vs (46.1 and 31.3%), improvement in QoL as measured […]
Shots: The two P-III POETYK PSO-1 and POETYK PSO-2 trials evaluating deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) @16wks. and vs Otezla @24wks. in 666 and 1,020 patients with the mod. to sev. plaque psoriasis respectively The trials met its co-1EPs & 2EPs i.e @16wks., PASI 75 (58.7% and 53.6%) vs (12.7% and […]
Shots: The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence […]
Shots: The P-III withdrawal study involves assessing the efficacy and safety of Xywav (oral solution) vs PBO in a ratio (1:1) in adult patients with idiopathic hypersomnia. The study includes a titration and optimization period of up to 14wks. followed by a 2wks. open-label, SDP The study demonstrated a change in ESS score within 2wks., […]
Shots: The second P-III BRAVE-AA1 trial involves assesing the efficacy and safety of Baricitinib (2mg/4mg, qd) vs PBO in adults with a SALT score ≥ of 50 (i.e., who had ≥50% scalp hair loss) in addition to current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs […]
Shots: The P-IIb POC Study 201 involves assessing lecanemab in patients with early AD Results: @18mos, prespecified analysis showed a consistent reduction of clinical decline across several clinical and biomarker EPs at highest doses and reduction in brain Aβ & clinical decline. The results are published in a peer-reviewed journal In March, the companies have […]
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 mNIS+7 @9mos. & improvement in QoL assessed by Norfolk QoL-DN and gait speed […]
Shots: The company reported new post hoc data from the P- III ASCLEPIOS trials assessing Kesimpta (ofatumumab) vs teriflunomide in a subgroup of newly diagnosed, treatment-naïve patients with RMS The results showed a 60% reduction in the risk of disability progression independent of relapse activity @3 and 6 mos., thus supporting Kesimpta as a 1L […]
Shots: The P-II Vivacity-MG study involves assessing the safety, tolerability, efficacy, PK, PD, and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG The 1EPs of the study include safety, tolerability, and efficacy assessed by (MG-ADL) ADL score. The 2EPs includes the efficacy as measured by […]
Shots: The P-III COV-BARRIER study involves assessing Baricitinib (4mg, qd) + SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) vs PBO + SoC in 1525 patients in a ratio (1:1) hospitalized with COVID-19 The trial did not meet 1EPs i.e. progression to non-invasive ventilation or invasive mechanical ventilation including […]
Shots: The P-III study is designed to assess caregivers’ perspectives on the long-term seizure & non-seizure-related benefits of Fintepla on patients with Dravet syndrome and on their caregivers and families Results: seizure-related benefits noted by caregivers include a reduction in frequency, seizure activity, and shorter recovery time while non-seizure benefits include improvements in executive functions […]
Shots: The 2-year data from Part 2 of P-II/III FIREFISH study involves assessing Evrysdi in 41 infants aged 1-7mos. with symptomatic Type 1 SMA Results: improvement in maintained motor function b/w 12-24mos., babies were able to sit without support for at least 5sec. after 24mos. vs 12mos. (61% vs 29%), 92% maintained the ability to […]
Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as a 2L treatment for advanced or m-sqNSCLC The trial met its 1EP i.e improvement in OS, mOS (11.79 vs 8.25 mos.), mPFS (4.30 vs 2.79 mos.), ORR (25.5% vs 2.2%), […]
Shots: The P-II KINETIC study involves assessing the efficacy, safety, and tolerability of SAGE-324 (60mg, qd) vs PBO in 69 patients in a ratio (1:1) aged 18-80yrs. with essential tremor for 29 days The study met its 1EPs i.e reduction from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score @29day (36% vs […]
Shots: The P-III CheckMate-816 study involves assessing Opdivo (360mg) + CT (q3w for 3 doses) vs CT, followed by surgery as a neoadjuvant treatment in 358 patients with resectable stage Ib to IIIa NSCLC The study met its 1EPs, i.e. improvement in pCR (24% vs 2.2%) and showed improvement in 2EPs i.e. MPR (36.9% vs […]
Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs 13.8 mos.), ORR (80.8% vs 47.7%), CR (33.9% and 14.6%), […]
Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs PBO in 1,505 people to prevent symptomatic infection in household contacts of individuals infected with COVID-19 The trial met its 1EP and 2EPs showed an 81% reduction in the risk […]
Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs i.e DFS while the trial will continue to evaluate its […]
Shots: The company reported the data from the N-MOmentum trial involves assessing Uplizna in patients with NMOSD The results from the N-MOmentum trial demonstrated a reduction in pain, long-term safety, and efficacy outcomes. Additional results from the new survey demonstrated NMOSD patient attitudes towards diagnosis and treatment Uplizna is the first FDA-approved B-cell depleter to […]
Shots: The P-III study evaluating BNT162b2 (COVID-19 Vaccine) vs PBO in >44,000 participants age ≥16 yrs with 927 confirmed symptomatic cases of COVID-19 The results demonstrated that BNT162b2 is 91.3% effective against COVID-19, follow-up time of at least 6 mos after the 2nd dose, 100% effective in preventing severe disease by CDC, 95.3% effective against […]
Shots: The P-II PULSAR trial involves assessing Sotatercept (0.3 mg/kg or 0.3 mg/kg, SC, q3w) vs PBO in 106 patients in a ratio (3:3:4) with PAH. The results were published in NEJM The results of the P-II PULSAR study that demonstrated sotatercept has the potential to provide benefits to patients with PAH on top of […]
Shots: The P-III ASPEN-1 trial evaluating the efficacy and safety of DaxibotulinumtoxinA (either 125 unit or 250 unit dose) for injection vs PBO in adults with cervical dystonia, patients followed for a maximum of 36 wks in post-treatment The results showed median duration effect of up to 24 wks, as determined by time to loss […]
Shots: The P-III ILLUMINATE-A Study involves assessing Lumasiran vs PBO in 39 patients with age 6 or older in a ratio (2:1) for PH1 The study met its 1EPs demonstrated a 53.5% reduction in urinary oxalate excretion from baseline to 6 mos. i.e. change in 24 hrs. The 2EPs showed 84% of patients achieved normal […]
Shots: The P-II/III RELATIVITY-047 (CA224-047) study involves assessing the FD combination of relatlimab (160 mg) + Opdivo (480mg) vs Opdivo (480mg, IV, q4w) alone in 714 patients in a ratio (1:1) with previously untreated metastatic or unresectable melanoma The study met its 1EPs of the PFS while the follow-up for 2EPs of OS and ORR […]
Shots: The P-III LIBERTY withdrawal study involves assessing Relugolix combination therapy [relugolix (40 mg) + estradiol (1.0mg) & norethindrone acetate (0.5mg)] vs PBO in women with uterine fibroids for 24wks. The study met its 1EPs i.e. achieving the sustained responder rate @76wks. (menstrual blood loss < 80 mL) (78.4% vs 15.1%). The study met 2EPs […]
Shots: The P-I/II Stellar trial involve assessing QR-421a in 20 patients with usher syndrome and non-syndromic retinitis pigmentosa (nsRP) due to USH2A exon 13 mutations for 24mos. Results: QR-421 demonstrated benefit on multiple measures of vision, including best-corrected visual activity (BCVA), static perimetry, and retinal imaging (OCT) and was well-tolerated with no observed SAEs and […]
Shots: The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a […]
Shots: The P-III D8110C00001 study involves assessing AZD1222 vs PBO in 32,449 participants in a ratio (2:1) aged ≥18yrs. across 88 trial centers in the US, Peru and Chile to prevent COVID-19. his primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from total participants The study showed 76% efficacy against symptomatic […]
Shots: The P-IIIa STEP 4 trial involves assessing the safety and efficacy of Semaglutide (2.4 mg, SC, qw) vs PBO in adults with obesity for 68wks. The participants who reached the maintenance dose of semaglutide, during a 20wks. run-in period were randomized to either continue treatment with the therapy or switch to PBO for 48wks. […]
Shots: The P-III trial involves assessing REGEN-COV (casirivimab & imdevimab, 1200/2400mg, IV) vs PBO in non-hospitalized patients with COVID-19 The trial met its 1EPs i.e. showed a reduction in the risk of hospitalization and death with both doses by 70% /71% respectively and met its 2EPs including the ability to reduce symptom duration. The P-II […]
Shots: Insulet reported the results from the first pivotal trial of Omnipod 5 System in patients with T1D. The trial enrolls two groups that include 28 adults & adolescents aged 14-70yrs. and 112 children aged 6-13.9yrs. Results: In adults & adolescents and children, increase in time in range (70-180mg/dL) from 65% to 74% (additional 2.2hr/day) […]
Shots: The ongoing P-III OLE study involves assessing Vosoritide (15 mcg/kg) vs PBO in 119 children with achondroplasia. The CHMP opinion is expected in Europe in June 2021 The results demonstrated increased AGV, baseline mean AGV of 4.28 cm/year, sustained restoration of a major portion of the growing deficit and improved height z-score through the […]
Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed a mean beta-SG expression (54% vs 36%); IF positive fibers […]
Shots: The ongoing study involves assessing SRP-9003 (IV, with a one-time infusion) in children aged 4-15yrs. with LGMD2E. The study has cohort 1 (low dose-dose cohort, 1.85×1013 vg/kg) and cohort 2 (high-dose cohort, 7.41×1013 vg/kg), post-treatment biopsies were taken @60days The cohort 1 @24mos. showed a mean beta-SG expression (54% vs 36%); IF positive fibers […]
Shots: The IDMC has recommended stopping the enrollment in the P-III COMET-ICE trial due to evidence of profound efficacy. The study involves assessing VIR-7831 (GSK4182136) vs PBO in 583 patients for the early treatment of COVID-19 in adults at high risk of hospitalization The results demonstrated an 85% reduction in hospitalization or death and were […]
Shots: The P-III BLAZE-1 study involves assessing Bamlanivimab (700 mg) + Etesevimab (1400 mg) vs PBO in 769 COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization The results demonstrated an 87% reduction in hospitalizations and death with significant improvements in 2EPs The data support the use of […]
Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx. period (88% vs 17), low (150 mg/kg) and high dose […]
Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO for 7days The study showed the antiviral activity b/w dose […]
Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. The study did not meet its 1EPs of OS The company will continue to evaluate the therapy in ongoing P-III CANOPY-1 and CANOPY-A studies evaluating canakinumab in 1L and adjuvant […]
Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%) participants having HIV-1 RNA ≥50 c/mL. The 2EPs @96 wks. […]
Shots: The P-III BRAVE-AA2 study involves assessing Baricitinib (2mg & 4mg, qd) vs PBO in 546 adults with a SALT score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs @36wks. and demonstrated significant improvement […]
Shots: The P-III SURPASS-2 trial involves assessing Tirzepatide (5/10/15mg) vs Semaglutide (1mg) in 1,879 patients in a ratio (1:1:1:1) with T2D inadequately controlled with ≥1500 mg/day metformin alone for 40wks. Results: A1C reduction: (-2.09% /-2.37%/-2.46% vs- 1.86%); Weight reduction: (-7.8/-10.3/-12.4kg vs -6.2 kg); patients achieving A1C <7% (5.5%/88.9%/ 92.2% vs 81.1%); patients achieving A1C <5.7% […]
Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA Results: @median follow-up 22.4mos., patients that are alive and event-free (69% vs 43%); patients achieved MRD negative remission (93% vs 24%); @36mos. OS was (81.1% […]
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 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/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in […]
Shots: The P-IIa POC OSCAR study involves assessing the efficacy and safety of otilimab (90mg, IV) + SOC vs PBO + SOC in 806 hospitalized adults with aged 18-79yrs. with severe COVID-19 related pulmonary disease The study showed a 5.3% overall treatment difference in all age patients but did not reach statistically significant. The pre-planned […]
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 […]
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 […]
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%); […]
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 […]
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 […]
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 […]
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%). […]
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.); […]
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% […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
Merck is discontinuing development of its two Covid-19 vaccine candidates. Instead, it plans to focus on two therapeutic candidates for the disease.
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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% […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 & […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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%), […]
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 […]
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 […]
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%, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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) […]
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 […]
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 […]
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 > […]
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: […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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% […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]