First patient enrolled in Phase III CHARM study to evaluate BIIB 093 for the prevention and treatment of severe cerebral edema.- Biogen

Biogen announced the enrollment of the first patient in the global Phase III clinical study CHARM , designed to evaluate BIIB 093 (intravenous (IV) glibenclamide) for the prevention and treatment of severe cerebral edema in large hemispheric infarction (LHI), one of the most severe types of ischemic stroke where brain swelling (cerebral edema) often leads to high morbidity and mortality.

The CHARM study is an international, multicenter, randomized, double-blind, placebo-controlled, Phase III study that aims to enroll 680 patients with LHI in approximately 20 countries. It will evaluate the efficacy and safety of IV glibenclamide treatment within 10 hours following stroke onset. The primary endpoint is the modified Rankin Scale (mRS), a functional outcome, assessed at 90 days.