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Regeneron Pharmaceuticals has started Phase III clinical trials of its double antibody cocktail, REGN-COV2, for the treatment and prevention of Covid-19.
The company is initially conducting, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), a Phase III trial to assess REGN-COV2 for prevention of infection in people with close exposure to a Covid-19 patient.
The drug candidate has entered the Phase II/III part of two adaptive Phase I/II/III being conducted to evaluate the cocktail for treating hospitalised and non-hospitalised patients.
Progress is based on a positive review from the Independent Data Monitoring Committee, which analaysed Phase I safety data in an initial cohort of 30 hospitalised and non-hospitalised patients.
Regeneron Pharmaceuticals co-founder, president and chief scientific officer 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.”
The Phase III Covid-19 prevention trial, which will enrol approximately 2,000 patients at around 100 sites in the US, will investigate SARS-CoV-2 infection status.
Meanwhile, the two Phase II/III treatment trials in hospitalised and non-hospitalised patients will involve approximately 1,850 and 1,050 patients, respectively, at around 150 sites across the US, Brazil, Mexico and Chile.
These treatment studies will monitor virologic and clinical endpoints, with preliminary data expected to be available in the coming months.
Last week, Regeneron and its partner Sanofi reported that rheumatoid arthritis drug Kevzara failed to meet its primary and key secondary endpoints in Covid-19 patients who required mechanical ventilation in a Phase III trial in the US.