The REGN-COV2 clinical program will include populations of hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that have a high risk of exposure (healthcare workers or first responders, for example) and uninfected people with close exposure to a COVID-19 patient (such as a housemate). The placebo-controlled trials will be conducted at multiple sites, according to a news release.
Using its proprietary genetically modified VelocImmune mice, which have a human immune system and antibodies isolated from humans who recovered from COVID-19, Regeneron scientists evaluated thousands of fully human antibodies. They then selected the two most potent, non-competing and virus-neutralizing antibodies and scaled them up for clinical use. The antibodies bind non-competitively to the critical receptor-binding domain of the virus’ spike protein, which diminishes the ability of mutant viruses to escape treatment.
Tarrytown, N.Y.-based Regeneron used the same “rapid response” approach to develop its REGN-EB3 antibody treatment for Ebola that is under review by the FDA. Its first two adaptive Phase 1 and 2 studies for the COVID-19 cocktail evaluate virologic and safety endpoints and virologic and clinical endpoints, respectively. Data from both studies will be used to refine endpoints and determine the size for Phase 3 studies.
“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,” Regeneron co-founder, president & chief scientific officer Dr. George Yancopoulos said in the news release. “REGN-COV2 could have a major impact on public health by slowing the 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.”