Regeneron Pharmaceuticals (NASDAQ:REGN) said on Monday it began late-stage clinical trials to assess the effectiveness of its antibody cocktail in preventing and treating COVID-19.
The trial, run jointly with the National Institute of Allergy and Infectious Diseases, would test the therapy’s ability to prevent infection in those who have had close exposure to a COVID-19 patient.
The Tarrytown, New York-based pharmaceutical company went on to say the clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.
The Phase 3 prevention trial is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the U.S.; the trial will assess SARS-CoV-2 infection status.
The two Phase 2/3 treatment trials in hospitalized (estimated enrollment =1,850) and non-hospitalized (estimated enrollment =1,050) patients are planned to be conducted at approximately 150 sites in the U.S., Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer.
According to Regeneron Co-Founder George D. Yancopoulos, "We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic.
"We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine."
Shares in REGN catapulted $7.55, or 1.2%, early Monday to $630.00.
