GSK and Vir Biotechnology announce submission of Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19
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Issued: London, UK and San Francisco, US GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136) an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalisation or death. The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA. Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in?bioRxiv?in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant. GSK and Vir?will continue discussions with the European Medicines Agency (EMA) and other global regulators to?make?VIR-7831?available to patients with COVID-19 as soon as possible. About COMET-ICE The multi-centre, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, 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-hospitalised adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial. In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrolment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed. The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalised participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation for at least 24 hours or death within 29 days of randomisation. About the VIR-7831 Clinical Development Programme In addition to the COMET-ICE trial, the full COMET clinical development programme for VIR-7831 includes:- COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
- COMET-TAIL:?A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalisation or death due to COVID-19.
- COMET-STAR:?A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.