Sanofi to halt development of tolebrutinib for primary progressive MS
Sanofi announced that the Phase 3 PERSEUS study of tolebrutinib did not meet its primary endpoint for delaying disability progression in patients with primary progressive multiple sclerosis (PPMS). The company will not seek regulatory approval for this indication.
Sanofi has announced that its drug candidate tolebrutinib will not be advanced for the treatment of primary progressive multiple sclerosis (PPMS).
The Phase 3 PERSEUS study, which compared tolebrutinib to a placebo, failed to meet its primary endpoint. This endpoint measured the delay in time to onset of 6-month composite confirmed disability progression. Consequently, Sanofi will not pursue regulatory registration for the drug for PPMS.
Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi, stated that the company is disappointed with the study results. He added that the findings are expected to enhance the understanding of the underlying disease biology of multiple sclerosis. Sanofi extended its gratitude to the study participants and healthcare professionals.
Preliminary analysis indicated that the safety profile of tolebrutinib was consistent with previous studies, although drug-induced liver injury (DILI) remains an identified risk. Sanofi will continue to evaluate tolebrutinib for non-relapsing secondary progressive multiple sclerosis (SPMS), for which it received provisional approval in the UAE and is under review in the EU and other global markets.