Sanofi Winthrop Industrie announced that positive results from the HERCULES phase 3 study, published in The New England Journal of Medicine (NEJM), showed that tolebrutinib delayed disability progression in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS), a condition with no currently approved treatment options.
The company noted that the findings further support the differentiated mechanism of oral, brain-penetrant tolebrutinib, targeting disability progression independent of relapse activity.
The regulatory submission for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adult patients is being evaluated under priority review by the US Food and Drug Administration with a target action date of September 28, 2025.
The regulatory submission dossier is currently under review in the EU, with a decision expected in the first quarter of 2026.
Sanofi noted that the HERCULES data demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo. Additionally, results from the GEMINI 1 and 2 phase 3 studies, evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS) were also published in NEJM and presented today during the Clinical Trials Plenary Session at the AAN 2025 Annual Meeting.
According to the company, the GEMINI 1 and 2 results did not show superiority on the primary endpoint of reducing annualized relapse rate (ARR) over teriflunomide. The ARR during the study period was 0.13 in the tolebrutinib group and 0.12 in the teriflunomide group in GEMINI 1 and was 0.11 in both groups in GEMINI 2. A pooled analysis for a key secondary endpoint, not controlled for multiplicity, showed that tolebrutinib delayed the time to onset of 6-month confirmed disability worsening by 29% versus teriflunomide.
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