Vir Biotechnology Shares Are Trading Lower As COVID-19 Study VIR-7831 Arm To Stop Enrollment

Vir Biotechnology Inc (NASDAQ: VIR) and GlaxoSmithKline plc (NYSE: GSK) have provided an update on the VIR-7831 (GSK4182136) arm of NIH-sponsored ACTIV Program Phase 3 trial in hospitalized adults with COVID-19.

• The companies were informed that VIR-7831 could continue to the next phase of the ACTIV-3 trial as no reported safety signals were observed.
• But the sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.
• The independent Data and Safety Monitoring Board has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature.
• The recommendation is based on pre-planned safety, and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.
• The companies will continue discussions with the NIH.
• VIR-7831 is an investigational, dual-action monoclonal antibody.
• The company is also evaluating VIR-7831 in the outpatient setting, including:
  • COMET-ICE Phase 3 trial to evaluate VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death.
  • BLAZE-4 (sponsored by Eli Lilly), Phase 2 trial to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. 
• Price Action: VIR shares dropped 29.6% at $40.78, and GSK shares are down 0.44% at $33.94 on the last check Wednesday.