Regeneron COVID-19 antibody treatment offers 70 percent reduction in hospitalization and death in Phase 3 trial

Topline results from a phase three trial of the Regeneron Pharmaceuticals, Inc. COVID-19 antibody treatment, REGEN-COV, are in, demonstrating 70 percent reductions in hospitalization or death and shortened symptom durations.

The results were not overly affected by dosage. Across three dosage levels, all presented similar efficacy. Such results have prompted Regeneron to push for adding a lower 1,200 mg dose for its emergency use authorization from the Food and Drug Administration (FDA). The FDA itself recently updated its EUA fact sheets to note that REGEN-COV was the only authorized monoclonal antibody treatment to maintain potency against COVID-19 variants as well.

“This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting,” Dr. Suraj Saggar, trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey, said. “With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death.”

The trial put the treatment to the test on 4,567 infected, non-hospitalized patients. A companion phase two trial added to its successes, showing that even the lowest doses tested — 300 mg by IV and 600 mg by subcutaneous — provided significant viral load reductions over the first seven days of study.

According to Dr. George Yancopoulos, president and chief scientific officer for Regeneron, the data from the phase three trial will also be used to pursue a full Biologics License Application.