Monoclonal Antibody Cocktail Found Effective in Hospitals Too
Regeneron Pharmaceuticals, Inc. announced on September 30, 2021, that a trial assessing investigational REGEN-COV™ in patients hospitalized with COVID-19 met its primary endpoint.
Clinical trial results show that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without mounting their antibody response (seronegative) and required low-flow or no supplemental oxygen (p=0.0172).
Numeric improvements with REGEN-COV were observed for all clinical endpoints, including a 36% reduced risk of death by day 29 in the overall population, increasing to 56% reduced risk in patients who were seronegative at baseline.
And similar efficacy was observed with both doses (2,400 mg and 8,000 mg).
The trial also had clinical results supporting the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed.
"COVID-19 continues to have a devastating impact on patients, our communities, and healthcare systems, and has so far killed more than one in every 500 Americans," commented Eleftherios Mylonakis, M.D., Ph.D., primary investigator of the trial and Professor of Medicine, Molecular Microbiology and Immunology, and Director of Infectious Disease at Brown University and the Lifespan hospitals, in a press release.
The U.S. FDA is currently reviewing the request to add treatment in hospital settings to REGEN-COV authorization, says the company.
REGEN-COV is an investigational medicine authorized by the FDA under an emergency use authorization to treat people at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in specific post-exposure prophylaxis settings.
In the U.S., it is not currently authorized in patients who are hospitalized due to COVID-19 infection.
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Regeneron (NASDAQ: REGN) is a leading biotechnology company located in Tarrytown, NY, which invents life-transforming medicines for people with serious diseases.