Regeneron Pharmaceuticals has announced the commencement of Phase 3 trial with its investigational double-antibody cocktail REGN-COV2 to treat and prevent Covid-19 disease.
The trial is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Regeneron has used the potent, non-competing and virus-neutralising antibodies to create REGN-COV2, and scale up it with the firm’s in-house VelociMab and manufacturing capabilities.
Regeneron has also advanced the REGN-COV2 into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials designed to evaluate the cocktail’s potential to treat hospitalised and non-hospitalised patients with Covid-19.
Regeneron has decided to conduct the Phase 3 prevention trial at around 100 sites. The trial, which will recruit up to 2,000 patients in the US, will evaluate SARS-CoV-2 infection status.
The two-phase 2/3 treatment trials in hospitalised and non-hospitalised patients are planned to be carried out at around 150 sites in the US, Brazil, Mexico and Chile.
With preliminary data expected to be revealed later this summer, the trial will assess virologic and clinical endpoints.
According to the company, all trials are adaptively-designed and the numbers of patients enrolled will be based on trial progress and insights from Phase 2 studies.
Regeneron president and chief scientific officer Dr George Yancopoulos said: “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.
“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.”
In February this year, Regeneron expanded its collaboration with the US Department of Health and Human Services (HHS) to develop antibody treatments for novel coronavirus (2019-nCoV).