San Fran biotech, GSK seeking EUA for COVID-19 monoclonal antibody treatment

Vir Biotechnology, a San Francisco biotech startup, and GlaxoSmithKline said they will submit an Emergency Use Authorization (EUA) application to FDA after positive trial results of their monoclonal antibody treatment for COVID-19.

An Independent data monitoring committee (IDMC) recommended that a Phase 3 trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment because of evidence of profound efficacy, the two pharmaceutical manufacturers said in a press release.

Related: FDA grants emergency use for COVID-19 treatment

VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays, according to the companies. “In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop,” they said.

“The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics,” said George Scangos, Ph.D., CEO of Vir.

“These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus.”

In November, FDA granted an EUA for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly and Company) to treat mild-to-moderate COVID-19 in adult and pediatric patients. The agency has since approved other monoclonal antibody treatments for SARS-CoV-2.

Related: FDA clears Regeneron’s COVID-19 monoclonal antibody treatment and a home test

Vir Biotechnology and GlaxoSmithKline are also seeking emergency use authorizations for the treatment in other countries.

The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo. VIR-7831 was also well tolerated, according to the pharma makers.

“As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed,” they said.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company. The trial is designed to assess the safety and efficacy of bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralising antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.

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