Regeneron to Continue Trial Evaluating Antibody Cocktail REGN-COV2 in Hospitalized COVID-19 Patients

Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA) has received the go ahead to continue the clinical study of its antibody cocktail drug to treat seriously-ill COVID-19 patients that had been paused due to a potential safety concern.

Regeneron’s decision to pause the trial was based on a recommendation from the independent data monitoring committee (DMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Based on a potential safety signal and an unfavorable risk/benefit profile at that time, the DMC had recommended that further enrollment of patients requiring high-flow oxygen or mechanical ventilation should be placed on hold pending collection and analysis of further data on patients already enrolled.

However, the DMC has now reviewed available safety and efficacy data for the 15,545 total patients randomized, including the 325 patients who were in the arm randomized to receive either REGN-COV2 or control. The DMC has advised that in the light of these data and the available external information, they saw no cogent reason to modify the protocol or intake to the study and recommended continuing recruitment of eligible patients to all study arms.

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