Tarrytown, New York: Regeneron Pharmaceuticals , Inc. said its double-antibody therapeutic cocktail intended to prevent and treat COVID-19 is entering clinical trials in phase 3. The therapy, called REGN-COV2, has entered phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the ability of the cocktail to treat patients with coronavirus infection in hospital and in non-hospital.
Phase 3 clinical trials will assess the therapy’s ability to prevent COVID-19 infection among healthy people who have had close contact with an infected person such as a housemate, according to the company. The trial is being conducted jointly with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The Phase 3 prevention trial will include as many as 2,000 participants at 100 sites around the US. Participants are administered either a prescription or placebo. A statement from Regeneron Pharmaceuticals said the trial will assess how well the drug works against the SARS-CoV-2 virus as compared to the placebo medication, and whether there are any safety concerns that arise.
The researchers will be studying whether the therapy can reduce the amount of virus shed by COVID-19 patients and improve clinical outcomes in phase 2/3 treatment trials. The trials involving 850 hospitalised patients and 1,850 non- hospitalised patients are planned to be conducted at approximately 150 sites in the US, Brazil, Mexico and Chile.
The company said all trials are adaptively planned, and the ultimate number of enrolled patients would depend on the success of the trials and the findings from Phase 2 studies.
“We are conducting simultaneous adaptive experiments to push as rapidly as possible to provide a potential solution for preventing and treating COVID-19 infections, even in the midst of an ongoing global pandemic,” said George D Yancopoulos, M.D. , Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. “We ‘re pleased to work with NIAID to study REGN-COV2 in our quest to further prevent the virus from spreading with an anti-viral antibody cocktail that could be available much sooner than a vaccine.”