French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) reported on Monday that tolebrutinib, its oral brain-penetrant BTK inhibitor, has shown positive results in a phase 3 study for non-relapsing secondary progressive multiple sclerosis (nrSPMS).

In the HERCULES study the drug met the primary endpoint of delaying the onset of confirmed disability progression in people with nrSPMS. While the GEMINI 1 and 2 studies did not meet the primary endpoint of reducing annualised relapse rate compared to teriflunomide in people with relapsing MS, secondary analysis showed a considerable delay in time to onset.

These results represent a significant breakthrough, as tolebrutinib could be the first treatment option for nrSPMS, a population with significant unmet medical need.

Sanofi is currently conducting another phase 3 study in primary progressive MS, with results expected in 2025.