Regeneron Pharmaceuticals, Inc. announced positive first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 in COVID-19 patients. REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients.
The company said it plans rapidly to discuss results with regulatory authorities.
The trial is part of a larger program that also includes studies of REGN-COV2 for the treatment of hospitalized patients, and for prevention of infection in people who have been exposed to COVID-19 patients.
REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed particularly to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
The ongoing, randomized, double-blind trial measures the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care. The descriptive analysis included the first 275 patients enrolled in the trial.
The latest results showed that REGN-COV2 reduced viral level and the time to reduce symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits.
Regeneron said it continues to enroll patients in this trial and all other ongoing late-stage trials evaluating REGN-COV2. At least 1,300 patients will be recruited into the Phase 2/3 portion of the outpatient trial overall.
David Weinreich, Senior Vice President and Head of Global Clinical Development at Regeneron, said, "We plan rapidly to submit detailed results from this analysis for publication in order to share insights with the public health and medical communities.
In addition to the trial in non-hospitalized patients, REGN-COV2 is currently being studied in a Phase 2/3 clinical trial for the treatment of COVID-19 in hospitalized patients, among others.
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