Regeneron Pharmaceuticals has begun a Phase III trial evaluating its double antibody cocktail for prevention of novel coronavirus infection in uninfected people who have had ‘close exposure’ to a COVID-19 patient in a Phase III trial.
The experimental therapy has also advanced into the Phase II/III segment of two adaptive trials assessing its ability to treat hospitalised and non-hospitalised patients with COVID-19, the firm noted.
This follows a positive review from the Independent Data Monitoring Committee of REGN-COV2 Phase I safety results in an initial cohort of 30 hospitalised and non-hospitalised patients with COVID-19.
The Phase III prevention trial is being conducted at approximately 100 sites and is expected to enrol 2,000 patients in the US; the trial will assess SARS-CoV-2 infection status.
The two Phase II/III treatment trials in hospitalised (estimated enrolment =1,850) and non-hospitalised (estimated enrolment =1,050) patients are planned to be conducted at around 150 sites in the US, Brazil, Mexico and Chile, and will evaluate virologic and clinical endpoints, with preliminary data expected later this summer.
“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, Regeneron’s co-founder, president and chief scientific officer.
“We are pleased to collaborate with NIAID to study REGN-COV2 in our quest to further prevent the spread of the virus with an antiviral antibody cocktail that could be available much sooner than a vaccine.”