A month after moving its COVID-19 antibody cocktail into human trials, Regeneron is starting a phase 3 study to see whether the drug can ward off infection in people exposed to COVID-19 patients.
To be conducted with the National Institute of Allergy and Infectious Diseases, the trial aims to enroll 2,000 patients through about 100 sites in the U.S. It will study whether the cocktail, dubbed REGN-COV2, can prevent infections in uninfected people who have come into close contact with COVID-19 patients, including the housemates of patients.
Last month, Regeneron started two adaptive phase 1/2/3 studies to test the antibody cocktail as a treatment for hospitalized and non-hospitalized patients. The phase 3 prevention study comes after a data monitoring committee gave a thumbs-up to early safety data from the phase 1 portions of those trials. Regeneron has also started the phase 2/3 part of those studies, which, together, aim to enroll nearly 3,000 patients across 150 sites in the U.S., Brazil, Mexico and Chile. The trials will assess virologic and clinical endpoints.
"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," said George Yancopoulos, M.D., Ph.D., chief scientific officer of Regeneron.
Unlike vaccines, which stimulate the body to produce antibodies against a pathogen, treatments like REGN-COV2 give patients ready-made antibodies to fight off the virus. And although multiple vaccine candidates are advancing at breakneck speed, Regeneron believes an antibody cocktail could be available “much sooner than a vaccine” and could be useful in the long run to protect certain patient groups, such as elderly and immunocompromised patients.
Amgen, AstraZeneca, GlaxoSmithKline and Eli Lilly are among the other drug developers working on antibodies that could be used to treat or prevent COVID-19 infection. Of the group, AstraZeneca and Regeneron have chosen to test a combination of two antibodies that target different areas of the receptor-binding domain on the new coronavirus’s spike protein. Using two antibodies rather than one could reduce the risk that a mutant, drug-resistant form of the virus will escape treatment and become the dominant strain.