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Regeneron Reports Positive Data with Antibody Cocktail Used to Prevent COVID-19

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January 27, 2021

By Rick Pezzullo—

Tarrytown-based Regeneron Pharmaceuticals, Inc. announced positive initial results from an ongoing Phase 3 clinical trial evaluating REGEN-COV, an antibody cocktail used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient.

The trial is being run jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

“These data using REGEN-COV as a passive vaccine suggest that it may both reduce transmission of the virus as well as reduce viral and disease burden in those who still get infected,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “Even with the emerging availability of active vaccines, we continue to see hundreds of thousands of people infected daily, actively spreading the virus to their close contacts.”

“The REGEN-COV antibody cocktail may be able to help break this chain by providing immediate passive immunity to those at high risk of infection, in contrast to active vaccines which take weeks to provide protection,” he added. “There are also many individuals who unfortunately may be immunocompromised and not respond well to an active vaccine or are otherwise unable to be vaccinated, and REGEN-COV has the potential to be an important option for these individuals. Overall, the REGEN-COV development program has demonstrated definitive anti-viral activity and the collective data strongly suggest it can be effective both as a therapeutic and as a passive vaccine.”

An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo. Fewer total symptomatic weeks (18 weeks placebo vs. 0 weeks REGEN-COV).

In the safety assessment, adverse events occurred more frequently in participants on placebo (18% placebo vs. 12% REGEN-COV); this difference was driven by the increased rate of SARS-CoV-2 infections in the placebo group. In the placebo group, there was one death and one COVID-19-related hospitalization; there were no deaths or COVID-19 hospitalizations in the treatment group. Injection site reactions occurred at a rate of approximately 2% in both treatment and placebo groups.

“In this prevention trial, REGEN-COV was given as injections rather than an infusion, which makes administration much more convenient and efficient for patients and overburdened healthcare providers and facilities,” said David Weinreich, M.D., Executive Vice President and Head of Global Clinical Development at Regeneron. “It’s notable that the few infections that did occur after receiving REGEN-COV were all asymptomatic, and associated with markedly lower viral load and duration of viral shedding, potentially further reducing transmission. We look forward to seeing the full dataset early next quarter and will discuss the current results with regulatory authorities, including the potential to expand the Emergency Use Authorization.”

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