Vir Biotechnology + GSK announce global expansion to phase III of COMET-ICE study evaluating VIR 7831 for the treatment of COVID-19.

Vir Biotechnology, Inc. and GlaxoSmithKline plc announced the global expansion to Phase III of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR 7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. VIR 7831 (also known as GSK 4182136) is a fully human antiSARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential ability to neutralise the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (the major site of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe. The Phase III portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR 7831 or placebo in approximately 1,300 non-hospitalised participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation. Interim analyses are planned to evaluate safety, futility and efficacy, the results of which may be available as early as the end of 2020. Results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021. The COMET clinical development programme for VIR 7831 includes two additional trials – one for the treatment of hospitalised patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in late 2020 evaluating VIR 7832, a second investigational SARS-CoV-2 neutralising antibody that shares the same characteristics as VIR 783, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.