Sanofi reports positive results from Phase 3 HERCULES study of tolebrutinib in multiple sclerosis

The results of the study showed that tolebrutinib delayed the time to “onset of disability progression confirmed at 6 months” in nrSPMS patients by 31 percent compared to placebo.

These results were presented today at the 2024 Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

The company also presented results from the Phase 3 GEMINI 1 and 2 studies of tolebrutinib compared to Aubagio, a standard of care, in participants with relapsing multiple sclerosis (RMS). Both studies failed to meet their primary objectives of a statistically significant improvement in annual relapse rate compared to Aubagio.

A Phase 3 trial of tolebrutinib, called PERSEUS, in primary progressive MS is currently underway; results are expected in the second half of 2025.

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