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Inhibition of CD40L with Frexalimab in Multiple Sclerosis
Patrick Vermersch1, Cristina Granziera1, Yang Mao-Draayer1
1From the University of Lille, INSERM Unité 1172, Lille Neuroscience and Cognition, Lille University Hospital, University Hospital Federation Precise, Lille (P.V.), and Sanofi, Chilly-Mazarin (S.S., R.B., P.T.) - both in France; Translational Imaging in Neurology Basel, Department of Biomedical Engineering, Faculty of Medicine, and the Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel, University Hospital Basel and University of Basel, Basel, Switzerland (C.G.); the Department of Neurology, Autoimmunity Center of Excellence, University of Michigan Medical Center, Ann Arbor, and the Michigan Institute for Neurological Disorders, Farmington Hills (Y.M.-D.); the Department of Biostatistics, University of Alabama at Birmingham School of Public Health, Birmingham (G.C.); the Department of Neurology, Dnipro State Medical University, Dnipro, Ukraine (O.K.); the Clinic of Neurology and Sleep Medicine, Acibadem City Clinic University Hospital Tokuda, Sofia, Bulgaria (I.S.); the First Department of Neurology, St. Anne's University Hospital, Brno, Czech Republic (M.D.); Sanofi, Cambridge, MA (B.D., E.W.); and Queen Mary University of London, London (G.G.).
Frexalimab, an anti-CD40L antibody, significantly reduced new brain lesions in multiple sclerosis patients compared to placebo. Further trials are needed to confirm long-term efficacy and safety of this multiple sclerosis treatment.
Area of Science:
- Neuroimmunology
- Immunotherapy
Background:
- The CD40-CD40L pathway is crucial for immune responses and implicated in multiple sclerosis (MS) pathogenesis.
- Frexalimab is an investigational anti-CD40L monoclonal antibody for MS treatment.
Purpose of the Study:
- To evaluate the efficacy and safety of frexalimab in patients with relapsing multiple sclerosis.
- To assess the reduction of new MRI lesions as a primary endpoint.
Main Methods:
- Phase 2, double-blind, randomized trial with 129 participants with relapsing MS.
- Participants received intravenous (1200 mg) or subcutaneous (300 mg) frexalimab, or placebo, for 12 weeks.
- Primary endpoint: new gadolinium-enhancing T1 lesions at week 12.
Main Results:
- Frexalimab significantly reduced new gadolinium-enhancing T1 lesions compared to placebo.
- Adjusted mean lesions: 0.2 (1200 mg IV), 0.3 (300 mg SC) vs. 1.4 (placebo).
- Secondary imaging endpoints supported primary findings; common adverse events included COVID-19 and headache.
Conclusions:
- Frexalimab demonstrated efficacy in reducing new MRI lesions in MS patients over 12 weeks.
- The anti-CD40L therapy showed a favorable effect compared to placebo.
- Longer-term studies are necessary to establish the overall efficacy and safety profile of frexalimab for multiple sclerosis.
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