Regeneron has initiated its first human clinical trials evaluating an investigational antiviral antibody cocktail, REGN-COV2, for the prevention and treatment of coronavirus disease 2019 (COVID-19).

According to the Company, REGN-COV2 consists of 2 of the most potent, noncompeting and virus-neutralizing antibodies among thousands that were evaluated. The two antibodies bind noncompetitively to the critical receptor binding domain (RBD) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein.

“We have created a unique antiviral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral ‘escape,’ a critical precaution in the midst of an ongoing global pandemic,” said George D. Yancopoulos, MD, PhD, Co-Founder, President and Chief Scientific Officer of Regeneron. 

The antibody cocktail will be evaluated in 4 separate study populations: hospitalized COVID-19 patients, nonhospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders) and uninfected people with close exposure to a COVID-19 patient (such as a household member). The first 2 adaptive, placebo-controlled phase 1/2/3 studies will assess the efficacy and safety of REGN-COV2 in hospitalized and nonhospitalized COVID-19 patients.

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The Company has also implemented new technologies to allow for large-scale manufacturing and purification of these investigational antiviral antibodies. “REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine,” said Yancopoulos.

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