Sanofi Announces Positive Phase 3 Results for Tolebrutinib in Non-Relapsing Secondary Progressive MS

Sanofi today announced positive results from the Phase 3 HERCULES trial evaluating tolebrutinib in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The trial met its primary endpoint, demonstrating a statistically significant 31% reduction in the risk of 6-month confirmed disability progression compared to placebo. Tolebrutinib is a brain-penetrant BTK inhibitor that targets both B cells and microglia, which are key drivers of neuroinflammation and neurodegeneration in MS. This is the first Phase 3 trial to demonstrate a significant reduction in disability progression in nrSPMS, a form of MS with very limited treatment options. Sanofi plans to submit regulatory applications based on these results.