Phase II trial shows frexalimab is high-efficacy therapy in relapsing MS

Positive Phase II clinical trial demonstrated frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS), corresponding to 89% and 79% reduction in new gadolinium-enhancing (GdE) T1 brain lesions at Week 12 in the high- and low-dose treatment arms compared to placebo, meeting the study’s primary endpoint.

Published in the New England Journal of Medicine, the findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.

Frexalimab is French pharma major Sanofi’s (Euronext: SAN) novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion.