Double Coronavirus Antibody Cocktail Launches Phase 3 Study
A New York based pharmaceutical firm announced the initiation of late-stage clinical trials evaluating an investigational double-antibody cocktail for the treatment and prevention of COVID-19 disease.
Regeneron Pharmaceutical’s REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.
Announced on July 6, 2020, the Phase 3 prevention trial will evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient, such as the patient's housemate.
This study is being conducted at approximately 100 sites and is expected to enroll 2,000 patients in the USA.
Additionally, REGN-COV2 has moved into the Phase 2/3 portion of an adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19, in approximately 150 sites, which are located in the USA, Brazil, Mexico and Chile.
This clinical progress follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.
"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 D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron, in a press statement.
According to the Company, Regeneron’s scientists evaluated fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.
They selected the 2 most potent, non-competing, and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company's in-house VelociMab® and manufacturing capabilities.
REGN-COV2's two antibodies bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications.
More recent research also demonstrates coverage against the now prevalent D614G variant.
A listing of SARS-CoV-2 treatments can be found at CoronavirusToday.
Precision Vaccinations published COVID-19 treatment news.
- REGENERON ANNOUNCES START OF REGN-COV2 PHASE 3 COVID-19 PREVENTION TRIAL IN COLLABORATION WITH NIAID
- SARS-CoV-2 Spike protein variant D614G increases infectivity and retains sensitivity to antibodies that target the receptor
- Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail
- Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies
- COVID-19 Disease Treatments