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Vir Biotechnology (VIR) and GlaxoSmithKline (GSK) announced last night that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of "profound efficacy."

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, the primary endpoint of the trial. VIR-7831 was well tolerated, the companies added. 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. Based on these results, Vir and GSK plan to submit an Emergency Use Authorization application to the Food and Drug Administration and for authorizations in other countries. Data from this registrational trial will also form the basis for a Biologics License Application submission to the FDA. The companies also announced the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the U.K., South African, and Brazilian variants, based on in vitro data from pseudotyped virus assays.

"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," Vir and GSK said.