Regeneron Launches Phase 3 Clinical Trial of Antibody Cocktail REGN-COV2 for Prevention of SARS-CoV-2 Infection

On July 6, Regeneron announced the initiation of a Phase 3 clinical trial to evaluate the efficacy of its investigational dual-antibody cocktail therapy, REGN-COV2, in preventing SARS-CoV-2 infection among previously uninfected individuals who had close contact with confirmed COVID-19 patients. This clinical trial will be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). Meanwhile, the adaptive clinical trial evaluating REGN-COV2 for the treatment of both hospitalized and non-hospitalized COVID-19 patients has advanced into its Phase 2/3 segment.

REGN-COV2 consists of two monoclonal antibodies that bind to the key receptor-binding domain (RBD) of the SARS-CoV-2 spike protein. These two antibodies target distinct RBD binding sites; therefore, their combined use can reduce the virus’s ability to evade monotherapy through genetic mutations. Preclinical studies on these two antibodies were recently published in Science. In the Phase 1 clinical trial, a review by the independent data monitoring committee of the initial cohort comprising 30 hospitalized and non-hospitalized COVID-19 patients found that REGN-COV2 demonstrated a favorable safety profile.

The Phase 3 prevention trial currently underway is being conducted at approximately 100 research centers and is expected to enroll 2,000 participants in the United States; this trial will assess SARS-CoV-2 infection status. The Phase 2/3 treatment trials, involving hospitalized (estimated enrollment = 1,850) and non-hospitalized (estimated enrollment = 1,050) patients, are planned to be conducted at approximately 150 research centers across the United States, Brazil, Mexico, and Chile. These trials will evaluate virologic and clinical endpoints, with preliminary data expected in late summer of this year. All trials feature adaptive designs, and the final number of enrolled participants will depend on trial progress and the results of the Phase 2 studies.

Dr. George D. Yancopoulos, Co-Founder, President, and Chief Scientific Officer of Regeneron, said, “We are conducting adaptive trials in parallel to provide a potential solution for the prevention and treatment of COVID-19 infection as quickly as possible. We are pleased to collaborate with NIAID on the study of REGN-COV2 to further help halt the spread of the virus.”

References:

[1] Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID). Retrieved 2020-07-06, from http://www.prnewswire.com/news-releases/regeneron-announces-start-of-regn-cov2-phase-3-covid-19-prevention-trial-in-collaboration-with-national-institute-of-allergy-and-infectious-diseases-niaid-301088202.html

Original Title: To Prevent SARS-CoV-2 Infection, Regeneron Initiates Phase 3 Clinical Trial of Antibody Cocktail Therapy

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