Monoclonal Antibody from Vir and GSK is 85 Percent Effective

Vir Biotechnology and GlaxoSmithKline’s monoclonal antibody for COVID-19 reduced hospitalizations or death from the infection by 85 percent in a phase 3 trial, according to the companies — and they have stopped enrollment in the trial because of the therapy’s “profound efficiency.”

Based on the positive results, Vir and GSK say they plan to file for emergency use authorization (EUA) from the FDA and seek authorizations in other countries as well.

The two companies developed VIR-7831/GSK4182136 as a monotherapy for early treatment of COVID-19 in adults at high risk of hospitalization. The late-stage trial’s independent data monitoring committee recommended ending enrollment based on an interim analysis of data from 583 patients.

The companies also said another, not-yet-published study had shown that VIR-7831 is effective against current circulating SARS-Cov-2 variants of concern, including the UK, South African and Brazilian variants.

“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 Vir CEO George Scangos. “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 contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope — the specific piece of the antigen to which an antibody binds — of the coronavirus spike protein, so even when the virus mutates the antibody should still recognize the conserved epitope and give protection against the variant strain.

The trial is ongoing, with patients continuing to be followed for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming, Vir and GSK said. — Suz Redfearn