IDMC recommends changes to trials of REGN COV2 in COVID-19.- Regeneron Pharma

Regeneron Pharmaceuticals received a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. Specifically, based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommends further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled. The IDMC also recommends continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts. Finally, the IDMC recommends continuation of the outpatient trial without modification. Regeneron remains blinded to the data and is implementing the IDMC recommendations. Regeneron is also informing the FDA, which is currently evaluating REGN-COV2 for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes. Regeneron is also sharing the recommendation with the independent committee monitoring the RECOVERY trial in the UK, which is evaluating REGN-COV2 in hospitalized patients.