P-II/III

RedHill’s Opaganib (ABC294640) Fails to Meet its Primary Endpoints in P-II/III Study for the Treatment of Severe COVID-19

Shots: The P-II/III study evaluates opaganib +SoC vs PBO + SoC in a ratio (1:1) in 475 patients with COVID-19 pneumonia requiring hospitalization & treatment with supplemental oxygen The preliminary data showed that the study did not meet its 1EPs while efficacy EPs showed consistent trends. The therapy demonstrated good tolerability with balanced AEs & …

RedHill’s Opaganib (ABC294640) Fails to Meet its Primary Endpoints in P-II/III Study for the Treatment of Severe COVID-19 Read More »

Sanofi Stops the P-II/III STAGED-PKD Study of Venglustat for Autosomal Dominant Polycystic Kidney Disease

Shots: The company has stopped the P-II/III STAGED-PKD study for not meeting futility criteria that assess venglustat vs PBO in patients with ADPKD, following an independent analysis of the annualized rate of change in TKV The therapy did not bring a reduction in TKV growth rate and interim analysis showed the reduction of GSLs may …

Sanofi Stops the P-II/III STAGED-PKD Study of Venglustat for Autosomal Dominant Polycystic Kidney Disease Read More »

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents

Shots: The P-II/III TeenCOVE study involves assessing mRNA-1273 (two 100 µg doses) vs PBO in 3700+ participants in a ratio (2:1) aged 12 to <18yrs. in the US The study met its 1EPs i.e non-inferior immunogenicity and demonstrated 93% efficacy in seronegative participants after 14 days following the first dose, was generally well tolerated with …

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents Read More »

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Shots: Clover plans to initiate a global P-II/III efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the H1’2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021 Additionally, Clover discontinued their partnership with GSK to evaluate the S-Trimer vaccine candidate with GSK’s pandemic adjuvant …

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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 …

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GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Shots: Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant The study will evaluate the immunogenicity and safety profile of the chosen formulation and dosing regimen of CoVLP (two doses of 3.75µg combined with GSK’s adjuvant given 21 days apart) in healthy adults 18-64yrs. of …

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Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 …

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19 Read More »