- Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline (NYSE:GSK) have reported global expansion to Phase 3 for the study evaluating VIR-7831/GSK4182136, anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in high-risk patients.
- Expansion will now include additional sites in North America, South America and Europe.
- The Phase 3 portion of the COMET-ICE study in ~1,300 subjects, will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo. Primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. Results for primary endpoint is expected in Q1 2021, current estimates at January 2021
- Companies expect to start a Phase 1b/2a trial later this year evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831.
- Earlier this year, Vir and GSK collaborated for research and development of COVID-19 treatments.
- https://seekingalpha.com/news/3620093-vir-biotech-glaxos-anti-sars-covminus-2-antibody-advances-to-phase-3
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Tuesday, October 6, 2020
Vir Biotech/Glaxo's anti-SARS-CoV-2 antibody advances to Phase 3
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