GSK & Vir’s COVID-19 treatment shows 85% efficacy in Phase III trial
GSK and Vir Biotechnology have submitted an Emergency Use Authorization request to the FDA for their VIR-7831 therapy for the treatment of COVID-19.
The therapy is an investigational SARS-CoV-2 monoclonal antibody for the treatment of patients aged 12 years or older with mild-to-moderate COVID-19, who are at risk for progression to hospitalisation or death.
The submission is based on interim analysis of the companies’ Phase III COMET-ICE trial, which evaluated 583 patients. The study found an 85% reduction in hospitalisation or death in those receiving VIR-7831 as compared to the placebo; the trial was consequently stopped early due to evidence of profound efficacy.
This analysis suggests VIR-7831 is able to block viral entry into healthy cells, while clearing infected cells. The antibody binds to an epitope on the COVID-19 virus that is believed not to be able to easily mutate. The treatment has also been designed to have high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2.
VIR-7831 is also being evaluated in BLAZE-4, a Phase II trial sponsored by Eli Lilly, designed to assess the safety and efficacy of Lilly’s bamlanivimab alone, and bamlanivimab with other antibodies, including VIR-7831, versus placebo in low-risk adults with mild-to-moderate COVID-19.
Vir and GSK intend to continue clinical trials of their treatment themselves, including an upcoming Phase III trial to determine whether intramuscularly-administered VIR-7831 can prevent symptomatic infection in uninfected, high-risk adults.
GSK and Vir will continue discussions with the EMA and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.
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