French pharma company Sanofi has revealed new long-term data for its investigational oral Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib, which demonstrated a ‘promising’ safety and efficacy profile in patients with relapsing forms of multiple sclerosis (MS).

Results from the Phase IIb long-term extension study (LTS) showed that after 48 weeks of treatment, Sanofi’s BTK inhibitor reduced multiple sclerosis (MS) disease activity – as measured by magnetic resonance imaging (MRI).

Sanofi also revealed data on the effect of tolebrutinib on human microglia, which the company says supports it capacity to modulate neuroinflammatory processes directly within the central nervous system (CNS).

According to Sanofi, this data makes tolebrutinib the only BTK inhibitor in development for MS which has been shown to directly modulate microglia – based on ‘publicly available information’.

“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.

“For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients,” he added.

Currently, tolebrutinib is being evaluated in Phase III clinical trials for the treatment of RMS, non-relapsing secondary progressive MS (nrSPMS) and primary progressive MS (PPMS).

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