Regeneron Interrupts Covid-19 Trial Enrollment

Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in REGN-COV2 antibody cocktail treatment trials for Covid-19 because of a potential safety signal and an unfavorable risk/benefit profile at this time. The enrollment hold was based on a recommendation from the company’s independent data monitoring committee, which also recommended continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts. The hold should remain pending collection and analysis of further data on patients already enrolled, the committee said.

Regeneron says it remains blinded to the data and it has informed FDA, which is currently evaluating the therapy for a potential Emergency Use Authorization in mild-to-moderate outpatients at high risk for poor outcomes (see earlier story).