COVID-19 Outpatient Trial Demonstrates REGN-COV2 Antibody Cocktail Reduced Virus Levels

Regeneron Pharmaceuticals announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits).

"The first job of an antiviral therapeutic drug is to lower the viral load, and our initial data in 275 patients strongly suggested that the REGN-COV2 antibody cocktail could lower viral load and thereby potentially improve clinical outcomes. Today's analysis, involving more than 500 additional patients, prospectively confirms that REGN-COV2 can indeed significantly reduce viral load and further shows that these viral reductions are associated with a significant decrease in the need for further medical attention," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Regeneron has shared these results with the U.S. Food and Drug Administration as part of its review of our Emergency Use Authorization submission, and we continue to focus on completing our ongoing trials evaluating REGN-COV2 for the treatment and prevention of COVID-19."

The randomized, double-blind trial is measuring the effect of adding REGN-COV2 to usual standard-of-care, compared to adding placebo to standard-of-care. A descriptive analysis from the first 275 patients was previously reported. This data, involving an additional 524 patients, show the trial met all of the first nine endpoints in the statistical hierarchy, which assessed virologic endpoints based on viral load, seronegative status and dose group, as well as the key clinical endpoint of COVID-19 related medically-attended visits, in patients who had laboratory-confirmed COVID-19 at baseline. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams). Based on this finding, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2.

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.