GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) under Article 5(3) of Regulation 726/2004 and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation Application.
The review will include data from 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 randomised patients, 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. The CHMP review will also consider data on the medicine’s quality and safety.
This week, the Australian Therapeutic Goods Administration (TGA), part of the Department of Health, granted VIR-7831 a provisional determination. VIR-7831 is the first anti-SARS-CoV-2 monoclonal antibody to have been granted this designation which provides a formal and transparent mechanism for accelerating the registration of promising new medicines with preliminary clinical data.
VIR-7831 is an investigational compound and has not been granted a marketing authorisation anywhere in the world. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the US Food and Drug Administration (FDA).
Preclinical data suggest VIR-7831 targets a highly conserved epitope of the SARS-CoV-2 spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv 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 preclinical data published in bioRxiv, VIR-7831 also appears to maintain activity against the California variant.
GSK is planning to submit a full Marketing Authorisation Application (MAA) to the EMA which will include the data from the COMET-ICE trial.
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 defi...
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