Sanofi Presents New Long-Term Data on Tlebrutinib for Multiple Sclerosis
Sanofi shared new long-term data on the safety and efficacy of its investigational MS drug tolebrutinib at the ECTRIMS congress in October 2021.
Sanofi presented new data on the long-term safety and efficacy profile of its investigational brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib, at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2021.
The data, derived from a Phase 2b extension study involving patients with relapsing forms of multiple sclerosis (RMS), indicated a favorable tolerability of tolebrutinib over one year. Notably, 98 percent of patients remained on treatment throughout the 48-week extension period.
Results showed that tolebrutinib reduced multiple sclerosis disease activity as measured by MRI. Patients receiving the 60mg dose or switching to it experienced low levels of new gadolinium-enhancing lesions. Additionally, in vitro studies on human microglia supported tolebrutinib's potential to modulate neuroinflammatory signaling.
Sanofi stated that the data reinforce the promising safety and efficacy of tolebrutinib. The company highlighted that mean Expanded Disability Status Scale (EDSS) scores remained relatively stable throughout the treatment period. Common adverse events observed included headache (10%) and COVID-19 (9%).