Regeneron Pharmaceuticals initiated the first clinical trial of REGN-COV2, an antibody cocktail for the prevention and treatment of COVID-19.
The REGN-COV2 clinical program will consist of four separate study populations, including hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people that are high-risk, and uninfected people with close exposure to a COVID-19 patient.
“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,” George Yancopoulos, co-founder, president and chief scientific officer at Regeneron, said. “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. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches.”
Regeneron scientists evaluated thousands of human antibodies produced by the company’s proprietary VelocImmune mice, which have been genetically-modified to have a human immune system. They selected the two most potent virus-neutralizing antibodies and scaled them up for clinical use with the company’s manufacturing capabilities. The two antibodies bind to the critical receptor binding domain (RBD) of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment.
Regeneron used the same approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the U.S. Food and Drug Administration (FDA).
The Phase 1 portion will focus on virologic and safety endpoints, while the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine the size for the Phase 3 studies.
“We are particularly excited to begin studies of REGN-COV2, which is a novel antibody cocktail targeted specifically against SARS-CoV-2,” Suraj Saggar, chief of infectious disease at Holy Name Medical Center in Teaneck, N.J., said. “Over the last long months, we have learned that repurposing existing medicines, unfortunately, does not offer a broadly effective solution for COVID-19. For this reason, we need to investigate custom-designed approaches like REGN-COV2. The first studies will evaluate if REGN-COV2 can improve disease outcomes in both hospitalized and non-hospitalized patients with COVID-19.”