P-IIb

Sanofi Presents Results of Tolebrutinib in a P-IIb LTS for Relapsing Forms of Multiple Sclerosis at ECTRIMS 2021

Shots: The P-IIb LTS part A assesses tolebrutinib (5/15/30/60mg/day) in patients with RMS and in Part B, where all participants switched to the 60mg The study demonstrated a reduction in MS disease activity as MRI and showed a favorable 1yrs. tolerability. EDSS score (2.18 to 2.65), for 60/60mg treatment group, SD score (2.65 & 2.45); …

Sanofi Presents Results of Tolebrutinib in a P-IIb LTS for Relapsing Forms of Multiple Sclerosis at ECTRIMS 2021 Read More »

Xenon’s XEN1101 Meets its Primary Efficacy Endpoint in P-IIb X-TOLE Clinical Trial for the Treatment of Focal Epilepsy

Shots: The P-IIb X-TOLE clinical trial evaluates the efficacy, safety, & tolerability of XEN1101 (25/20/10mg) vs PBO in 325 & 323 patients (in the safety & ITT population, respectively) with focal epilepsy The trial met its 1EPs i.e., patients achieved a median reduction in monthly focal seizure frequency from baseline (52.8%/46.4%/33.2% vs 18.2%), and other …

Xenon’s XEN1101 Meets its Primary Efficacy Endpoint in P-IIb X-TOLE Clinical Trial for the Treatment of Focal Epilepsy Read More »

Janssen Presented Results of RSV Vaccine in P-IIb CYPRESS Study for Lower Respiratory Tract Disease Due to Respiratory Syncytial Virus at IDWeek 2021

Shots: The P-IIb CYPRESS study evaluates the efficacy & safety of RSV vaccine vs PBO in a ratio (1:1) in 5782 patients aged ≥65 with LRTD caused by RSV The study met its 1EPs & 2EPs i.e., 80% efficacy against RSV-associated LRTD & 70% against any symptomatic RSV-associated ARI. The vaccine showed robust humoral & …

Janssen Presented Results of RSV Vaccine in P-IIb CYPRESS Study for Lower Respiratory Tract Disease Due to Respiratory Syncytial Virus at IDWeek 2021 Read More »

Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV

Shots: The P-IIb study evaluates the efficacy & safety of remibrutinib vs PBO in 311 patients with CSU inadequately controlled by H1-antihistamines for 12wks. The results showed an improvement in UAS7 related to CFB @4 & 12wks. & rapid improvement as of 1wks., patients achieved UAS7=0 (complete absence of hives & itch) and UAS7≤6 (well-controlled …

Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV Read More »

Novartis Reports Results of ligelizumab (QGE031) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria

Shots: The P-IIb study evaluates ligelizumab (72/240mg) vs Xolair or PBO in patients with CSU with an inadequate control on antihistamines The results showed that proportion of patients achieved complete control of CSU symptoms @12 & 20wks. (44.1%/40.0% vs 23.5% & 0.0%) & (33.3%/34.1% vs 25.9% & 4.7%); CSU-free patients (38.1%/35.3% vs 18.8% & 0.0%) …

Novartis Reports Results of ligelizumab (QGE031) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria Read More »

Theravance Reports Results of Izencitinib in P-IIb Dose-Finding Induction Study for the Treatment of Ulcerative Colitis

Shots: The P-IIb dose-finding induction study evaluates izencitinib (PO, qd) vs PBO in 239 patients with a mod. to sev. active UC for 8wks. The results from the P-II study for CD is expected in late Q4’21 or early Q1’22 The study did not meet 1EPs & 2EPs of change in total Mayo score & …

Theravance Reports Results of Izencitinib in P-IIb Dose-Finding Induction Study for the Treatment of Ulcerative Colitis Read More »

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough

Shots: The P-IIb clinical trial involves evaluating the efficacy and safety of eliapixant (25/75/150mg, PO, bid) vs PBO in 300 patients with refractory chronic cough for 12wks. The trial met its 1EPs that showed an improvement in 24hrs. cough counts @12wks. of treatment. The results showed a favorable safety and tolerability profile of the therapy …

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough Read More »

Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

Shots: The P-IIb VISION-DMD study involves assessing the efficacy & safety of vamorolone (2&6 mg/kg/day) vs PBO and prednisone (0.75 mg/kg/day) in 121 ambulant boys aged 4 to <7 years with DMD for 48 wks. The study met its 1EP i.e improvement in TTSTAND velocity, following the 1st period @24 wks. The 2 EPs include …

Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy Read More »

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Shots: The last patient is out from the P-IIb part of its multinational P-IIb/III study of NP-120 for the COVID-19 has now completed treatment with 2wk follow up The company reports positive interim results for the P-IIb part of it P-IIb/III Ifenprodil COVID-19 study and expecting the final data set by end of Feb 2021 …

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19 Read More »

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Shots: The P-IIb study will evaluate three dose levels of ION449 (once a month, SC) vs PBO and will enroll ~108 patients aged 18-75yrs., who have LDL-C levels b/w 70-190 mg/dL and are receiving moderate/ high-intensity statin therapy The P-I study results demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90% …

AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol Read More »