Regeneron Pharmaceuticals announced the start of a phase 3 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, according to a FirstWord Pharma report. The company added that REGN-COV2 has also moved into the phase 2/3 portion of two adaptive trials testing the cocktail’s ability to treat hospitalized and non-hospitalized 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 hospitalized and non-hospitalized 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 program would consist of four separate study populations, with the first two adaptive phase 1/2/3 trials in hospitalized and non-hospitalized 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 enroll 2000 patients in the US. Meanwhile, the other two trials will recruit 1850 hospitalized and 1050 non-hospitalized patients in the US, Brazil, Mexico and Chile, with preliminary data expected later this summer.
REGN-COV2 combines the REGN10933 and REGN10987 neutralizing antibodies, which bind non-competitively to the receptor binding domain of the SARS-CoV-2 virus’ spike protein.