Phase 3 Studies Show Positive REGEN-COV Treatment Results
New York-based Regeneron Pharmaceuticals, Inc. announced today positive data from two clinical trials evaluating REGEN-COV™ (casirivimab with imdevimab).
The Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV 1,200 mg administered via subcutaneous (SC) administration, reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint) and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.
The second Phase 3 trial was jointly run with the National Institute of Allergy and Infectious Diseases. The trial enrolled 204 individuals without any COVID-19 symptoms who tested positive for the SARS-CoV-2 coronavirus but did not have anti-virus antibodies at baseline and were randomized to receive either 1 dose of REGEN-COV (1,200 mg) or placebo.
"COVID-19 transmission often occurs via infected people who do not yet have symptoms, so it is critical that we rapidly diagnose and treat these individuals for their own health and to prevent transmission," commented Katharine Bar, M.D., co-principal investigator of the trial and Assistant Professor of Medicine, Infectious Diseases, Hospital of the University of Pennsylvania, in a press statement.
"These data pave the way for REGEN-COV to be used before patients become symptomatic, with a more convenient subcutaneous administration."
The trial met all primary and key secondary endpoints. In addition to reducing the risk of symptomatic infections, the total number of weeks patients experienced symptoms was nearly cut in half (45%) with REGEN-COV, and the viral burden was reduced by more than 90%.
While not included in the initial analysis plan, researchers also found that 0 REGEN-COV patients and 6 placebo patients were either hospitalized or visited the emergency room because of COVID-19 during the 29-day efficacy assessment period.
The data build on previously announced results from the Phase 3 outcomes (2067) and Phase 2 virology (20145) trials in non-hospitalized COVID-19 patients.
"These Phase 3 data provide even more evidence that REGEN-COV, this time given to asymptomatic patients via convenient injections, can change the course of COVID-19 infection in non-hospitalized patients," added George D. Yancopoulos, M.D., Ph.D., President, and Chief Scientific Officer at Regeneron.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.