Another small piece of the cures against Covid chapter. GlaxoSmithKline and Vir Biotechnology have in fact announced that they have submitted the request to the American FDA to authorize the emergency use for VIR-7831, early treatment of Covid-19.
VIR-7831 (GSK4182136) is an investigational dual-action monoclonal antibody, for the treatment of adults and adolescents (12 years of age and older weighing at least 40 kg) with mild to moderate Covid-19 who are at risk progression to hospitalization or death.
The submission of the emergency authorization is based on an interim analysis of the efficacy and safety data from the phase 3 study Comet-Ice (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early), which evaluated VIR-7831 as monotherapy for the early treatment of Covid-19 in adults at high risk of hospitalization. The results of the interim analysis, based on data from 583 patients enrolled in the study, demonstrated an 85% (p = 0.002) reduction in hospitalization or death in those who received VIR-7831 compared to placebo. primary endpoint of the study. As a result, the Independent Data Monitoring Committee recommended discontinuing the study for enrollment due to evidence of profound efficacy. The data from the COMET-ICE registration study will also form the basis for submitting a biological license application (BLA) to the FDA.
Preclinical data suggest that VIR-7831 targets a highly conserved epitope of the spike protein, which can make resistance development more difficult. New in vitro data from pseudotyped virus tests published online on bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern, including those from the UK, South Africa and the Brazil. Based on further preclinical data to be published soon, VIR-7831 appears to maintain activity against the California variant as well.
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.
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