Sanofi and Regeneron have hustled up a second pivotal trial for their IL-6 drug Kevzara as a potential therapy for severe cases of Covid-19. The partners swiftly assembled a study drawing patients from Italy, Spain, Germany, France, Canada and Russia, planning to sign up 300 patients in a Phase II to test a low and high dose of Kevzara against placebo, setting the stage for the Phase III followup.
The theory, which Roche is putting to the test with their own pivotal trial with their IL-6 therapy Actemra, was in part inspired by a well understood pathway — tamping down on an overactive immune response — and buoyed by a single-arm study in China that suggested this was the right approach.