Sanofi: Tolebrutinib For NrSPMS Meets Primary Goal In HERCULES Trial; Fails In GEMINI Trial For RMS

(RTTNews) - French drug major Sanofi (SNYNF, SNY) announced Monday that its oral brain-penetrant Bruton's tyrosine kinase or BTK inhibitor Tolebrutinib, in the HERCULES phase 3 study, met the primary endpoint in delaying time to onset of confirmed disability progression in people with in non-relapsing secondary progressive multiple sclerosis or nrSPMS.

Further, results from the GEMINI 1 and 2 phase 3 studies evaluating tolebrutinib did not meet the primary endpoint of reducing annualized relapse rate (ARR), compared to teriflunomide, in people with relapsing forms of multiple sclerosis or RMS.

However, analysis of the key secondary endpoint of pooled 6-month CDW data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES.

Multiple sclerosis is a chronic, immune-mediated, neurodegenerative disease that results in accumulation of irreversible disabilities over time.

The company noted that Phase 3 study results will form the basis for future discussions with global regulatory authorities

HERCULES phase 3 study is the first and only to show reduction in disability accumulation, the company noted. In the latest trial, preliminary analysis of liver safety was consistent with previous tolebrutinib studies.

Houman Ashrafian, Head of Research & Development, Sanofi, said, "Tolebrutinib represents an unprecedented breakthrough as a potential first-in-disease treatment option with clinically meaningful benefit in disability accumulation. Addressing disability accumulation, thought to be driven by smoldering neuroinflammation, remains the greatest unmet medical need in people with non-relapsing secondary progressive MS today."

The company will present the study results for HERCULES and GEMINI 1 and 2 at the upcoming European Committee for Treatment and Research in Multiple Sclerosis or ECTRIMS medical meeting on September 20.

Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

The PERSEUS phase 3 study in primary progressive MS, evaluating time to onset of CDP, is currently ongoing with study results anticipated in 2025.

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