Sanofi's (SNY.US) drug failed to meet the primary endpoint in two relapsing multiple sclerosis trials.
Sanofi's (SNY.US) MS candidate tolebrutinib failed to meet the primary endpoints in two studies. In the GEMINI1 and GEMINI2 studies, the drug did not significantly reduce the annualized relapse rate compared to Sanofi's Aubagio (a purine synthesis inhibitor used to treat relapsing MS).
However, tolebrutinib did meet the primary endpoint in the HERCULES Phase 3 study, delaying the onset of confirmed disability progression in non-relapsing secondary progressive MS, which currently has no approved treatment.
Sanofi has been seeking multiple opportunities in the MS field as its popular MS drug Aubagio faces generic competition.
Sanofi is still testing tolebrutinib in the PERSEUS Phase 3 study to treat primary progressive MS and assess the time to onset of confirmed disability progression. Results are expected in 2025.