French drug major Sanofi S.A. (SNYNF,SNY) announced Wednesday positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab, showing significantly reduced disease activity in relapsing multiple sclerosis or MS.
frexalimab is the first second-generation anti-CD40L antibody to show efficacy in MS.
The Phase 2 study was a randomized, double-blind, placebo-controlled trial evaluating frexalimab in patients with relapsing MS.
The primary endpoint was the reduction in the number of new GdE T1-hyperintense MRI brain lesions after 12 weeks of treatment. Secondary endpoints included additional MRI-based efficacy measures as well as the safety, tolerability and pharmacokinetics of frexalimab.
In the trial, Frexalimab met primary endpoint with 89% reduction in new gadolinium-enhancing T1 brain lesions achieved at Week 12 in the higher-dose treatment arm, compared with placebo.
The new data is being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers or CMSC annual meeting.
Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, said, "Frexalimab has a unique mechanism of action, blocking the CD40/CD40L costimulatory pathway thought to regulate both adaptive and innate immune cell activation and function - a pathway that is pivotal in the pathogenesis of MS. We are thrilled with the results achieved with frexalimab in just 3 months, which shows that CD40L inhibition rapidly controls MS disease activity without lymphocyte depletion."
Sanofi said it plans to initiate pivotal trials in multiple sclerosis in early 2024.
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