GlaxoSmithKline/Vir suspends monoclonal antibody VIR-7831 and enrolls in key phase 3 clinical patients

Compilenewborn

On March 3, GlaxoSmithKline (GSK) and its partner Vir Biotechnology provided VIR-7831 (GSK4182136) in the Phase 3 clinical trial of the National Institutes of Health (NIH) Accelerated COVID-19 Therapeutic Intervention and Vaccine (ACTIV) Project ) Branch update.

According to the announcement, both parties have been informed that although VIR-7831 meets the initial pre-specified standards, it can proceed to the next stage of the ACTIV-3 test and no safety signals are reported, but the sensitivity analysis of the existing data has caused potential problems Worries about the size of the benefits.

The Independent Data and Safety Monitoring Board (DSMB) recommended that the VIR-7831 group of this trial should be discontinued before the data matures.

DSMB’s recommendations are based on a review of routine, pre-planned safety and efficacy data for the first 300 COVID-19 patients in ACTIV-3.

VIR-7831 is a dual-acting monoclonal antibody under development.

In addition to the ACTIV-3 trial, the following clinical trials are also evaluating VIR-7831 in outpatient clinics:

——COMET-ICE (Covid-19 Monoclonal Antibody Efficacy Trial-Early Care Purpose): A phase 3 trial to evaluate the early treatment effect of VIR-7831 on COVID-19 in hospitalized or high-risk adults.

-BLAZE-4 (sponsored by Eli Lilly and Company): A phase 2 trial designed to evaluate Eli Lilly's monoclonal antibody drug bamlanivimab (LY-CoV555) alone, bamlanivimab in combination with other neutralizing antibodies (including VIR-7831) The safety and effectiveness of medication, and the safety and effectiveness of placebo in low-risk adults with mild to moderate COVID-19.

In addition, VIR-7831 and VIR-7832 will be evaluated in adult patients with mild to moderate COVID-19 in the phase 1b/2a National Health Service (NHS) supported AGILE trial.

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