Regeneron Pharmaceuticals announced Monday the start of a Phase III study investigating the ability of the double antibody cocktail REGN-COV2 to prevent infection among uninfected people who have had close exposure to a COVID-19 patient. The company added that REGN-COV2 has also moved into the Phase II/III portion of two adaptive trials testing the cocktail's ability to treat hospitalised and non-hospitalised patients with COVID-19.
According to Regeneron, the clinical progress of REGN-COV2 comes after a positive review from the independent data monitoring committee of safety results from a Phase I study in an initial cohort of 30 hospitalised and non-hospitalised patients with COVID-19. "We are running simultaneous adaptive trials in order to move as quickly as possible…even in the midst of an ongoing global pandemic," remarked George Yancopoulos, the company's chief scientific officer.
Last month, Regeneron said that the first placebo-controlled study investigating REGN-COV2 for the prevention and treatment of COVID-19 had started. At the time, the company indicated that the clinical programme would consist of four separate study populations, with the first two adaptive Phase I/II/III trials in hospitalised and non-hospitalised patients with COVID-19, while other populations would include uninfected people who are at high-risk of exposure or who have close exposure to a COVID-19 patient.
Regeneron said that the prevention study, which is being run jointly with the National Institute of Allergy and Infectious Diseases, is expected to enrol 2000 patients in the US. Meanwhile, the other two trials will recruit 1850 hospitalised and 1050 non-hospitalised patients in the US, Brazil, Mexico and Chile, with preliminary data expected later this summer.
REGN-COV2 combines the REGN10933 and REGN10987 neutralising antibodies, which bind non-competitively to the receptor binding domain of the SARS-CoV-2 virus' spike protein.
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