President Donald Trump praised BCW Member Regeneron for its REGN-COV2 treatment, a combination of two monoclonal antibodies, which is still in clinical trials. The treatment is designed to prevent the infectivity of SARS-CoV-2, the virus that causes COVID-19.
President Trump received the treatment last week, according to his physicians. The Tarrytown pharmaceutical company Wednesday said it submitted an application to the Food and Drug Administration for emergency approval to develop a limited 50,000 doses of the experimental antibody cocktail.
REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. REGN-COV2 is currently being studied in two, Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
Two weeks ago the company announced that the result from Phase 1/2/3 trial were promising.
“After months of incredibly hard work by our talented team, we are extremely gratified to see that Regeneron’s antibody cocktail REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own, and were at greater risk for prolonged symptoms. We are highly encouraged by the robust and consistent nature of these initial data, as well as the emerging well-tolerated safety profile, and we have begun discussing our findings with regulatory authorities while continuing our ongoing trials. In addition to having positive implications for REGN-COV2 trials and those of other antibody therapies, these data also support the promise of vaccines targeting the SARS-CoV-2 spike protein.”
Founded by physician-scientists more than 30 years ago, Regeneron’s science-driven approach has resulted in seven FDA-approved medicines and numerous product candidates in a range of diseases, including cancer, asthma, pain and infectious diseases.