Sanofi says frexalimab reduced biomarker of nerve cell damage in Phase 2 data

Sanofi’s CD40L monoclonal antibody, frexalimab, reduced a key biomarker associated with multiple sclerosis nerve cell damage in patients with relapsing MS, supporting the rationale for this novel mechanism in MS phase 3 studies aiming to delay disability progression, the company announced. New phase 2 results showed significant reduction in plasma levels of neurofilament light chain after one year of treatment, a biomarker of nerve cell damage that is typically elevated in people living with MS. These data were presented at the 10th Congress of the European Academy of Neurology in Helsinki, Finland. Ninety-seven percent of the study participants from the initial 12-week double-blind period entered the open-label extension of the phase 2 study, and 87% remained in the study by the 48-week cut-off. NfL biomarker results from the phase 2 study showed: Plasma NfL levels were similar across all study groups at baseline and were reduced across all four treatment groups by week 48. Participants receiving high-dose frexalimab experienced a 41% reduction in plasma NfL levels from baseline, the greatest NfL level reduction across the four treatment groups. Participants receiving low-dose frexalimab experienced a 35% reduction in plasma NfL levels from baseline. Participants in the placebo-high group who switched to high-dose frexalimab at week 12 experienced a 24% reduction in plasma NfL levels from baseline and by 39% from week 12 when switched from placebo to high-dose frexalimab.