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VIR-7831 Submitted to FDA for EUA for the Early Treatment of COVID-19

The therapy showed significant efficacy in a Phase 3 trial and may be more difficult for variants to develop a resistance against.

GlaxoSmithKline, a science-led global healthcare company, and Vir Biotechnology, a clinical-stage immunology company, have announced that they have submitted an application to the US Food and Drug Administration (FDA) requesting an Emergency Use Authorization (EUA) for their investigational dual-action SARS-CoV-2 monoclonal antibody, VIR-7831 (GSK4182136), for the treatment of mild-to-moderate COVID-19 in individuals aged 12 years and older who are at risk for progression to hospitalization or death.

The companies submitted the EUA request based on an interim analysis of data on the efficacy and safety of the therapy from a Phase 3 trial called COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early).

In a previous Phase 2 trial, the lead-in portion to this one, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults. After a positive evaluation of safety and tolerability data, the Phase 3 portion of the trial was initiated.

The study, multi-center, double-blind, placebo-controlled trial, investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 3 trial assessed the safety and efficacy of a single IV infusion of 500 mg of VIR-7831 or a placebo in 583 non-hospitalized participants.

The primary efficacy endpoint was the proportion of patients who progressed to a point where they needed hospitalization for at least 24 hours or death within 29 days of randomization.

Results from the trial demonstrated that use of the therapy resulted in an 85% reduction in hospitalization or death in those receiving VIR-7831 compared to those who received the placebo. Because of these findings, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy.

Additional findings have suggested that the therapy may be more resistant to variants, due to it targeting a highly conserved epitope on the viral spike protein. In light of several strains of COVID-19 spreading throughout the world, this news could be of significant importance.

The 2 companies stated that they will continue discussing the therapy with other global health regulators in the hopes of making it available to patients as soon as possible.