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# Sanofi Multiple Sclerosis Trial Meets Endpoint
- URL: https://www.fdaweb.com/sanofi-multiple-sclerosis-trial-meets-endpoint/
- Published: 2023-05-31T12:00:00.000Z
- Updated: 2026-09-14T18:35:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154578

Sanofi says data from a Phase 2 trial of frexalimab, a novel second-generation investigational anti-CD40L antibody, “significantly reduced disease activity” in patients with relapsing multiple sclerosis. “Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the study’s primary endpoint,” it says. A pivotal Phase 3 study is planned for early 2024.

The company says the monoclonal antibody is believed to work by blocking the “costimulatory CD40/CD40L cellular pathway necessary for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion. The drug is being developed under an exclusive license from ImmuNext.