Regeneron Pharmaceuticals announced more positive findings from its ongoing Phase III trial on the use of REGEN-COV to prevent COVID-19 in uninfected persons who have been exposed to the virus.
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Regeneron Pharmaceuticals announced more positive findings from its ongoing Phase III trial on the use of REGEN-COV to prevent COVID-19 in uninfected persons who have been exposed to the virus.
The latest results show that REGEN-COV was able to reduce the risk for SARS-CoV-2 infection by 81.6% during the second to eighth month follow-up period and maintained an 81.4% risk reduction rate of 81.4% in the first month. REGEN-COV is composed of two monoclonal antibodies that block the infectivity of SARS-CoV-2 using the company’s VelociSuite and VelocImmune technologies.
In October, Regeneron announced that the U.S. Food and Drug Administration approved its Biologics License Application (BLA) for REGEN-COV and was given until April 13, 2022, to take action. The company is conducting two Phase III trials on more than 6,000 patients to evaluate the drug’s effectiveness as prophylaxis for asymptomatic individuals living with a person infected with the virus and as a treatment for those infected but not hospitalized.
The most recent results refer to a pre-specified analysis for the following seven months, during which 45 more symptomatic infections were observed. The study showed that REGEN-COV continued to prevent infection even without requiring more doses. During the eighth month evaluation period, no individuals were hospitalized while on REGEN-COV compared to the six logged under the placebo group.
The new analysis covers observations on 1,683 participants who did not have the SARS-CoV-2 virus and did not have antibodies at baseline (seronegative). The age range was 12 to 92 years, with the median age at 43 years.
“Today’s new data demonstrate how a single dose of REGEN-COV can help protect people from COVID-19 for many months after administration. These results demonstrate that REGEN-COV has the potential to provide long-lasting immunity from SARS-CoV-2 infection, a result particularly important to those who do not respond to COVID-19 vaccines including people who are immunocompromised,” said Myron S. Cohen, M.D., director of the Institute for Global Health & Infectious Diseases at the University of North Carolina, Chapel Hill, in a statement. Dr. Cohen also heads the monoclonal antibody efforts for COVID Prevention Network.
REGEN-COV is not approved for use by the FDA in the U.S. yet but holds an emergency use authorization (EUA) for individuals ages 12 years and older. It is also authorized to treat individuals who are at high risk for severe consequences related to COVID-19. It is not authorized as a substitute for vaccination, pre-exposure prophylaxis, or in hospitalized patients who require oxygen therapy.
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