Vir Biotechnology Inc. (NASDAQ: VIR) shares jumped on Tuesday after the firm announced, in conjunction with GlaxoSmithKline PLC (NYSE: GSK), that they would be expanding their late-stage COVID-19 study.
Specifically, the firms announced the global expansion to Phase 3 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 hospitalization.
Note that VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs (one of the major sites of infection).
This comes after a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee in late September. As a result, the firms will be expanding their sites in North America, South America and Europe.
Ultimately, the Phase 3 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-hospitalized participants globally. Note that this number is significantly smaller than many other companies currently in Phase 3 studies.
The primary efficacy endpoint is the proportion of patients who have a progression of COVID-19 as defined by the need for hospitalization or death within 29 days. The company expects interim analysis by the end of the year, with results from the primary endpoint in the first quarter, as early as January.
Vir Biotechnology stock traded up 8% to $42.10 early Tuesday. It has a 52-week range of $11.65 to $75.00 and a consensus price target of $52.14.
GlaxoSmithKline stock traded at $37.47, in a 52-week range of $31.43 to $48.25. The consensus price target is $48.67.