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

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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.
 

Related Articles (GSK + VIR)

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Posted-In: Covid-19Biotech News Health Care FDA General

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