US company Vir Biotechnology (Vir) and UK pharmaceutical giant GlaxoSmithKline (GSK) announced on Thursday that their coronavirus drug demonstrated a significant reduction in hospitalization and death among patients during early treatment.
According to the companies, an Independent Data Monitoring Committee (IDMC) recommended cutting short the Phase 3 trial of their monoclonal-antibody drug, called VIR-7831, due to overwhelmingly positive results.
“The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) 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 said in a statement.
The statement adds that the drug remains effective against various coronavirus strains, including the UK, South African and Brazilian variants.
“These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. 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,” Vir CEO George Scangos said.
Now Vir and GSK are planning to apply for the emergency use authorization with the US Food and Drug Administration, as well as similar authorizations in other countries.