Mixed tolebrutinib results but Sanofi remains confident

Sanofi (Euronext: SAN) has announced results from the HERCULES Phase III study, with BTK blocker tolebrutinib meeting the primary efficacy endpoint in non-relapsing secondary progressive multiple sclerosis (nrSPMS).

This makes tolebrutinib the first treatment to show a reduction in disability accumulation for this condition, addressing a significant unmet need for patients who currently have no approved therapies.

However, in the GEMINI 1 and 2 studies, tolebrutinib did not achieve the primary endpoint of reducing the annualized relapse rate compared to Aubagio (teriflunomide) in relapsing multiple sclerosis (RMS).