Biotechnology company Regeneron Pharmaceuticals said that it is launching a series of clinical trials to test the safety and efficacy of an investigational antibody cocktail for the treatment and prevention of COVID-19.
According to a company press release, Regeneron, of Tarrytown, NY, will conduct placebo-controlled trials of REGN-COV2 at multiple sites in four different populations: hospitalized COVID-19 patients, non-hospitalized patients with COVID-19 symptoms, uninfected people in high-risk groups such as healthcare workers, and uninfected people in close contact with infected patients. The first two trials will focus on virologic, safety, and clinical end points in hospitalized and non-hospitalized patients.
REGN-COV2 consists of two virus-neutralizing antibodies that bind non-competitively to the critical receptor binding domain of the spike protein that SARS-COV-2 (the virus that causes COVOD-19) uses to enter cells. The antibodies were selected from thousands of antibodies produced by mice that have been genetically engineered by the company to have a human-like immune system, and from patients who have recovered from COVID-19.
The hope is that the cocktail of antibodies, which mimic the type of antibodies the human immune system produces if exposed to SARS-CoV-2 or a vaccine, can both prevent and treat coronavirus infections. The company also says preclinical studies indicated that REGN-COV2 may reduce the potential for viral escape, which occurs when a virus mutates to evade the body's immune response.
"We have created a unique anti-viral 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 Regeneron president and chief scientific officer George Yancopoulos, MD, PhD. "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."
