Regeneron Pharmaceuticals is making changes to the Phase 3 trial of its Regen-COV treatment for outpatients with COVID-19.
The changes come at the recommendation of the Independent Data Monitoring Committee (IDMC), which said to no longer use a placebo group in the trial. IDMC found clear clinical efficacy on reducing the rate of hospitalization and death with both the 1,200 mg and 2,400 mg doses of Regen-COV compared to placebo and recommended stopping enrollment into the placebo group.
Regeneron will immediately stop enrolling patients in the placebo group, but the trial will continue to enroll patients into both the 1,200 mg and 2,400 mg Regen-COV treatment groups. The company will share detailed results when available in March 2021.
“We appreciate the time and guidance of the IDMC and are extremely grateful to the thousands of patients and investigators who have participated in this more than 8,000-patient clinical trial,” Dr. David Weinreich, executive vice president and head of global clinical development at Regeneron, said. “Regen-COV is now available in the U.S. to indicated high-risk non-hospitalized patients under an Emergency Use Authorization (EAU), and we hope to submit these results as part of a full Biologics License Application.”
The development and manufacturing of Regen-COV have been partially fund by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response.
“In addition to the clear-cut efficacy that the IDMC has observed in this trial, it’s reassuring that preclinical data from our labs and independent researchers show that Regen-COV effectively neutralizes emerging strains of the virus, which are becoming increasingly common,” Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said. “Our cocktail approach using two functionally-independent antibodies safeguards against variants that may impact potency to a single antibody.”
Regen-Cov is a cocktail of two monoclonal antibodies designed to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. In November, Regen-COV received Emergency Use Authorization from the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 in adults and kids older than 12 who tested positive for COVID-19.