PARIS—French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). However, it failed to meet the endpoint of reducing the annualized relapse rate in the GEMINI 1 and 2 studies, which assessed the molecule in patients with relapsing MS compared to Sanofi’s own therapy Aubagio (teriflunomide).
Sanofi, aiming to become the first company to successfully apply a BTK inhibitor to MS treatment, faces a setback with these results. The company had previously licensed orelabrutinib, a BTKi, to Biogen (Nasdaq: BIIB) for MS development in 2021, but Biogen returned the rights to Beijing InnoCare Pharma Tech Co., (09969.HK) last year following safety issues during trials.
The HERCULES study’s focus on nrSPMS patients, who no longer experience relapses but continue to see worsening disabilities, highlights a currently untreated patient group. Sanofi has indicated that the positive results from this study will be used as a foundation for future discussions with global regulatory authorities regarding tolebrutinib’s potential application in MS treatment.
With one more Phase III trial ongoing for tolebrutinib in primary progressive MS, expected results in 2025, Sanofi continues to seek breakthroughs in the treatment of this complex disease.- Flcube.com
