Sanofi Presents Data from Phase 2b Long-Term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis

Sanofi Presents Data from Phase 2b Long-Term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis

Sanofi presented data from a Phase 2b long-term extension study (LTS) evaluating tolebrutinib in patients with relapsing forms of multiple sclerosis (RMS). The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). These data are being presented as ePosters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13 – 15, 2021.

The LTS enrolled patients who had completed a previous phase 2 dose-finding study. Ninety-eight percent (122/125) of LTS-treated patients remained in the Phase 2b extension study through Week 48. The LTS consisted of Part A, a double-blind treatment period where patients continued the same tolebrutinib dose as administered in the dose-finding study (5, 15, 30, or 60mg/day) and Part B, where all patients switched to the 60mg tablet (5/60mg, 15/60mg, 30/60mg, 60/60mg). 

At baseline, mean Expanded Disability Status Scale (EDSS) scores across treatment groups ranged from 2.18 to 2.65. Over 48 weeks of treatment, mean EDSS scores remained relatively stable in all treatm...

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