Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, demonstrated favourable one-year tolerability in a phase 2b long-term extension study (LTS) 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).
The data is being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on 13-15 October 2021.
“Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS,” said Erik Wallström, Therapeutic Area Head, Neurology Development at Sanofi.
After 48 weeks, 98% of LTS-treated patients remained in the phase 2b extension study and mean MRI lesion activity remained low in patients who started on or switched to tolebrutinib 60mg.
The extension study was designed to evaluate the safety of tolebrutinib and provided the opportunity to evaluate efficacy parameters and report MRI outcomes.
“Results showed favourable safety and efficacy for tolebrutinib, and nearly all patients remained enrolled at the one-year mark of the long-term extension study,” said Anthony Traboulsee, Professor and Research Chair, MS Society of Canada at University of British Columbia and Phase 2b Extension Study Investigator.
“Evaluating the impact BTK inhibitors can have on preventing disability accumulation is critical to addressing the needs of people living with MS. These long-term outcomes of tolebrutinib reinforce its potential as a new treatment option for MS patients,” he added.