Sanofi's Tolebrutinib Fails to Meet Primary Endpoints in Two Phase 3 Trials for Relapsing Multiple Sclerosis

Intelligent Finance APP learned that Sanofi S.A. (SNY.US)’s multiple sclerosis (MS) candidate drug, tolebrutinib, did not meet the primary endpoints in two studies. In the GEMINI 1 and GEMINI 2 studies, compared with Sanofi’s Aubagio (a pyrimidine synthesis inhibitor used to treat relapsing multiple sclerosis), the drug did not significantly reduce the annualized relapse rate.

However, tolebrutinib did meet the primary endpoint of the HERCULES Phase 3 study, which is to delay the onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis, for which there are currently no approved treatments.

Due to the competition from generic drugs for another popular multiple sclerosis medication, Aubagio, this French pharmaceutical company has been seeking multiple opportunities in the multiple sclerosis field.

Sanofi is still testing Tolabutinib in the PERSEUS Phase 3 study to treat primary progressive multiple sclerosis and evaluate the time to onset of confirmed disability progression. The study results are expected to be released in 2025.