CHARM study will evaluate IV glibenclamide for the prevention and treatment of severe cerebral edema in LHI, one of the most severe types of ischemic stroke with limited treatment options
Prior studies demonstrated IV glibenclamide may potentially improve functional outcomes and reduce mortality, supported by imaging measures of brain swelling and biomarkers
Study initiation advances Biogen’s position in its emerging growth area of acute neurology
News Releases
BIOGEN ENROLLS FIRST PATIENT IN GLOBAL PHASE 3 STUDY OF BIIB093 (IV GLIBENCLAMIDE) FOR LARGE HEMISPHERIC INFARCTION
September 4, 2018 at 11:30 AM UTC
CHARM study will evaluate IV glibenclamide for the prevention and treatment of severe cerebral edema in LHI, one of the most severe types of ischemic stroke with limited treatment options
Prior studies demonstrated IV glibenclamide may potentially improve functional outcomes and reduce mortality, supported by imaging measures of brain swelling and biomarkers
Study initiation advances Biogen’s position in its emerging growth area of acute neurology
CAMBRIDGE, Mass., Sept. 04, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) announced today the enrollment of the first patient in the global Phase 3 clinical study CHARM, designed to evaluate BIIB093 (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.
“As pioneers in neuroscience, Biogen is dedicated to advancing innovative approaches for investigational drugs in acute neurological conditions with limited or no treatments by leveraging our core expertise,” said Michael Ehlers, M.D., Ph.D., executive vice president, research and development at Biogen. “We believe IV glibenclamide could represent a first-in-class therapy with the aim of giving physicians an effective option to improve patient outcomes and reduce mortality risk. LHI is a severe type of ischemic stroke with high mortality (40 percent to 80 percent) and no currently available therapy. BIIB093 has the potential to be the first major innovation in stroke in over 20 years, and we believe the advancement to Phase 3 represents a significant milestone in our stroke clinical program.”
Biogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV Glibenclamide) for Large Hemispheric Infarction | BiogenBiogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV Glibenclamide) for Large Hemispheric Infarction | Biogen
