Clinical Trials

Sanofi has announced new phase 2 trial data for its CD40L monoclonal antibody, frexalimab, for the treatment of patients with relapsing multiple sclerosis (MS).

The results showed a significant reduction in plasma levels of neurofilament light chain (Nf L) after one year of treatment, which is a biomarker of ner ve cell damage, typically raised in patients with MS.

Full results were presented at the 10th Congress of the European Academy of Neurolog y (EAN) in Helsinki, Finland. The results support the progression of the programme to phase 3 studies for the delay of disability progression.

According to the results of this study, participants receiving high-doses of the drug experienced a 41% reduction in plasma Nf L levels from baseline to week 48, and patients in the lower-dose group experienced a 35% reduction on plasma Nf L levels from baseline to week 48.

Erik Wallström MD PhD, global head of neurolog y development at Sanofi, commented: “People with multiple sclerosis need new high-efficacy treatment options that target disability progression, which remains an unmet need. These results, a longside the previously reported phase 2 efficacy and safety results, further show that frexalimab’s novel mechanism of action has the potential to deliver meaningful improvements for people living with this chronic and debilitating disease.”

Patrick Vermersch MD PhD, from the University of Lille, CHU Lille, France, added: “As our science and diagnostic tools have evolved, so has our understanding of multiple sclerosis. We now k now that Nf L levels may be related to both acute inflammatory damage and chronic diffuse neuronal loss leading to disability progression, strengthening its position as a key biomarker of ner ve cell damage in people with multiple sclerosis. These data presented at EAN suggest that CD40L inhibition may reduce ner ve cell damage in people with multiple sclerosis and reinforce the potential of frexalimab to slow or halt disease progression for people living with this disease.”