HERCULES phase 3 study of tolebrutinib to treat non-relapsing secondary progressive MS meets key primary endpoint : Sanofi

Positive results from the HERCULES Phase 3 study showed that tolebrutinib, Sanofi’s oral brain-penetrant BTK inhibitor, significantly delayed disability progression in patients with non-relapsing secondary progressive MS (nrSPMS) compared to placebo. The study found a 16% reduction in the risk of confirmed disability progression (CDP) over a median of 32 months. Preliminary liver safety results aligned with previous studies.

However, the GEMINI 1 and 2 studies did not achieve their primary endpoint of reducing annualized relapse rate (ARR) compared to teriflunomide in relapsing MS patients. Despite this, data from a key secondary endpoint showed a delay in CDP, supporting HERCULES findings.

The ongoing PERSEUS Phase 3 study in primary progressive MS is expected to report in 2025. Tolebrutinib's safety and efficacy are still under investigation and have not been evaluated by regulatory authorities.