Regeneron Pharmaceuticals, Inc., one of the leading biotechnology companies in New York, has announced in a press release on Monday, July 6, 2020, the start of its late-stage clinical trials evaluating REGN-COV2.
We have initiated a Phase 3 prevention trial for our investigational #COVID19 dual-antibody medicine in collaboration with @NIAIDNews (a part of @NIH). Read more: https://t.co/4GkTXzDRMM pic.twitter.com/DAYjFIPhzl
— Regeneron (@Regeneron) July 6, 2020
What is REGN-COV2
Regeneron’s REGN-COV2 is an investigational double antibody cocktail for the treatment and prevention of COVID-19.
Scientists from the biotech company have evaluated thousands of fully-human antibodies and selected the two most potent, non-competing, and virus-neutralizing antibodies to create REGN-COV2.
According to Regeneron, the two antibodies of REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.
The REGN-COV2 Phase 3 Prevention Trial
The Phase 3 COVID-19 prevention trial of REGN-COV2, as stated by Regeneron, is being done in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic. We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine.”
– George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron
Simultaneous with the prevention trial, REGN-COV2 is currently in Phase 2/3 clinical trials testing its ability to treat of COVID-19.
Two Thousand (2,000) patients are expected to be enrolled in the Phase 3 prevention trial which is being conducted at approximately 100 sites in the US.
Manufacturing of REGN-COV2
On a separate announcement by Regeneron and the U.S. Department of Health & Human Services on July 7, 2020, it was revealed that the Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services (HHS), and the Department of Defense (DOD) will collaborate with the biotech company on a large-scale manufacturing demonstration project of the COVID-19 investigational therapeutic treatment.
They are scaling up the manufacturing so that if clinical trials are successful and the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or product approval, it could be made immediately available in the United States.