An independent data monitoring committee "recommended that the Phase 3 … 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 companies said.
The recommendation "was based on an interim analysis of data from 583 patients enrolled in the trial, which demonstrated an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo.”
Vir recently traded at $73.90, up 58%, and Glaxo traded off 0.3% at $35.48.
VIR-7831 "was well tolerated,” the companies said. “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.”
The companies plan to apply for emergency-use authorization from the U.S. Food and Drug Administration and for authorizations in other countries.
In addition, “the results of a new study submitted and pending online publication in bioRxiv" show that VIR-7831 "maintains activity against current circulating variants of concern, including the U.K., South African and Brazilian variants.”
The study combined Lilly drugs bamlanivimab and etesevimab for patients recently diagnosed with COVID. Lilly shares at last check were 0.5% higher at $206.50.