06:50 AM EDT, 09/20/2024 (MT Newswires) -- Sanofi ( SNY ) said on Friday that the phase 3 study of its experimental drug, tolebrutinib, to treat non-relapsing secondary progressive multiple sclerosis showed delayed disability progression by 31% compared with placebo.

Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement nearly doubled.

The company said two other phase 3 studies of tolebrutinib failed to show a statistically significant improvement in annualized relapse rates compared to Aubagio, a standard-of-care treatment in multiple sclerosis patients.

However, a key secondary endpoint showed that tolebrutinib delayed the onset of disability worsening by 29%, in line with the results observed in participants with non-relapsing secondary progressive multiple sclerosis, the company added.

The analysis suggests that tolebrutinib may address neuroinflammation manifesting as progression independent of relapses.

The company said it would begin regulatory submissions by H2 2024.

It added that a phase 3 study of the drug to treat primary progressive multiple sclerosis is currently ongoing, with study results anticipated in H2 2025.

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