Sanofi will present new data from 14 abstracts, including three oral presentations, at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 congress in Barcelona from September 24 to 26. The company aims to highlight its ongoing work in multiple sclerosis (MS), focusing on biomarker innovation, symptom tracking, and efficacy and safety data from its investigational medicines tolebrutinib and frexalimab.
“Our comprehensive approach to multiple sclerosis research demonstrates how we are advancing science across the entire disease spectrum, from novel biomarkers to symptom management and treatment outcomes,” said Erik Wallström, MD, PhD, Global Head, Neurology and Ophthalmology Development at Sanofi. “By applying our deep understanding of the immune system, our innovative portfolio focuses on addressing the complex challenges of neuroinflammation and targeting the underlying causes of disease progression in multiple sclerosis to help people live for the moment, not the disease.”
Among the studies presented are subgroup analyses from the HERCULES phase 3 study on tolebrutinib’s effect on disability accumulation in non-relapsing secondary progressive MS (nrSPMS). Data from GEMINI 1 and 2 phase 3 studies will detail how tolebrutinib impacts progression independent of relapse activity in relapsing MS (RMS).
Additional findings include results from a phase 2 open-label extension evaluating frexalimab in RMS. These results reaffirm frexalimab’s potential as a high-efficacy, non-depleting medicine that may affect both acute and chronic neuroinflammation through immune regulation. Frexalimab is currently being studied further in phase 3 trials for RMS and nrSPMS.
The congress will also feature data assessing clinical and economic burdens faced by patients with SPMS in the United States. Qualitative patient assessment data underpinning a smoldering-associated worsening index will be shared, aiming to identify subtle early disability. The MS-DETECT study will present findings about digital biomarkers captured using MSCopilot technology in real-world settings.
Tolebrutinib is described as an oral Bruton’s tyrosine kinase inhibitor designed to target smoldering neuroinflammation—a factor believed to drive disability progression in MS—by crossing the blood-brain barrier and acting within the central nervous system. The drug previously received breakthrough therapy designation from the US Food and Drug Administration based on positive results from HERCULES phase 3 trial involving adults with nrSPMS. Tolebrutinib is currently under priority review by the FDA for treating nrSPMS and slowing disability accumulation independent of relapse activity; other regulatory applications are under review globally.
Frexalimab is an investigational anti-CD40L antibody being evaluated for its ability to regulate immune responses without depleting lymphocytes. It is undergoing clinical studies across several diseases beyond MS.
Sanofi states it remains committed to developing treatments that address neurological diseases such as MS, chronic inflammatory demyelinating polyneuropathy, Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, among others. The company has several neurology projects currently in phase 3 trials.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Forward-looking statements were included regarding future expectations about product development outcomes and regulatory decisions.
