Independent Data Monitoring Committee recommends Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial be stopped for enrollment due to evidence of profound efficacy

Decision based on interim analysis of data from 583 patients, which demonstrated significant reduction (p=0.002) in hospitalisation or death in patients receiving this investigational dual-action SARS-CoV-2 monoclonal antibody as monotherapy compared to placebo.

SPS commentary:

Companies plan to submit an Emergency Use Authorization application to FDA. Data from this trial will also form the basis for a Biologics License Application submission to the FDA.

Biospace Inc.