GlaxoSmithKline (GSK) and Vir Biotechnology have filed an application with the US Food and Drug Administration (FDA), seeking the Emergency Use Authorization (EUA) for VIR-7831 for the early treatment of Covid-19.

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody intended for treating mild-to-moderate Covid-19 in people aged 12 years and older, weighing at least 40 kg, and at risk for progression to hospitalisation or death.

The partnership between GSK and Vir Biotechnology was announced in April 2020, leveraging Vir’s monoclonal antibody platform technology and GSK’s expertise to identify and develop therapeutic agents against coronaviruses.

Phase 3 COMET-ICE trial supported GSK and Vir’s regulatory submission

The FDA EUA submission is based on an interim data from the Phase 3 COMET-ICE trial.

Phase 3 COMET-ICE is a multi-centre, double-blind, placebo-controlled trial evaluated VIR-7831 as monotherapy for the early treatment of Covid-19 in 583 patients at high risk of hospitalisation.

Patients treated with VIR-7831 demonstrated 85% reduction in hospitalisation or death compared to placebo, which is the primary endpoint of the trial.

Recently, an Independent Data Monitoring Committee recommended the halting of COMET-ICE trial due to profound efficacy, but the study is continuing to follow-up the participants for 24 weeks.

Also, data from the registrational COMET-ICE trial has supported the company in filing a Biologics License Application (BLA) with the US FDA.

According to the preclinical data, VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.

In other studies, VIR-7831 has maintained activity against current variants of Covid-19, including the UK, South African and Brazilian ones.

GSK stated: “Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.”

The two companies are planning to continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to Covid-19 patients soon.