Regeneron Drug maker announced plans Monday to begin Phase 3 clinical trials of a “double antibody cocktail” for use as a possible treatment for COVID-19.
The Phase 3 trial, the last stage of evaluation in the drug approval process, will assess the ability of the cocktail, called REGN-COV2, to prevent infection among uninfected people who have had “close exposure” to someone with COVID-19, company officials said.COVID-19 is the disease caused by the new coronavirus, SARS-CoV-2.
“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic,” Dr. George D. Yancopoulos, Regeneron’s co-founder, president and chief scientific officer, said in a statement yesterday.
The Phase 3 trial will be run by Regeneron and the National Institute of Allergy and Infectious Diseases. The cocktail, which is administered as a single IV infusion, is simultaneously undergoing Phase 2 and 3 trials designed to test its ability to treat hospitalized and non-hospitalized patients who have COVID-19, the company said.
The antibody cocktail is the result of research by company scientists in which thousands of fully human antibodies produced by Regeneron’s proprietary VelocImmune mice were evaluated along with antibodies collected from people who have recovered from COVID-19, according to Yancopoulos.
The VelocImmune mice have been genetically modified to have a human immune system, he said.
Scientists selected the two most potent antibodies against the new coronavirus to create REGN-COV2, which contains two antibodies that bind to the virus’s spike protein, diminishing the ability of mutant viruses to escape treatment and protecting against spike variants that have arisen in the human population, according to the company.
Researchers described the potential role for REGN-COV2 in an analysis published last month by the journal Science.
“We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an anti-viral antibody cocktail that could be available much sooner than a vaccine,” Yancopoulos said with immediate action from scientific investigation.