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Sanofi’s Frexalimab Shows Promise in Reducing MS Nerve Cell Damage

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Frexalimab, a CD40L monoclonal antibody developed by Sanofi, has shown significant potential in treating relapsing multiple sclerosis (MS) by reducing a key biomarker of nerve cell damage. New phase 2 data revealed a 41% reduction in plasma neurofilament light chain (NfL) levels, a biomarker associated with nerve cell damage, after 48 weeks of treatment.

These findings support frexalimab’s potential as a high-efficacy, disease-modifying treatment for relapsing MS and pave the way for ongoing phase 3 studies in both relapsing MS and non-relapsing secondary progressive MS (nrSPMS). Presented at the 10th Congress of the European Academy of Neurology (EAN) in Helsinki, Finland, the phase 2 study results demonstrated significant reductions in NfL levels.

Participants in the high-dose frexalimab arm experienced the greatest reduction, with NfL levels decreasing by 41% from baseline after 48 weeks. Low-dose frexalimab resulted in a 35% reduction, while participants initially on placebo who switched to high or low doses at week 12 saw reductions of 24% and 33%, respectively. These results highlight frexalimab’s potential to slow or halt disease progression in MS.

Promising Results for MS Treatment

Frexalimab’s novel mechanism of action involves blocking the CD40/CD40L pathway, crucial for activating and functioning adaptive and innate immunity. This mechanism allows frexalimab to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. Dr. Patrick Vermersch of the University of Lille emphasized the significance of these findings, noting that NfL levels are related to both acute inflammatory damage and chronic neuronal loss, making it a key biomarker for assessing nerve cell damage in MS patients.

The phase 2 study, a randomized, double-blind, placebo-controlled trial, involved 129 participants with relapsing MS. They were divided into groups receiving high-dose or low-dose frexalimab or placebo for 12 weeks, followed by an open-label extension where placebo groups switched to frexalimab. By week 48, 87% of participants remained in the study, with significant reductions in NfL levels observed across all treatment groups.

Dr. Erik Wallström, Global Head of Neurology Development at Sanofi, highlighted the urgent need for new high-efficacy treatments targeting disability progression in MS. He stated that the phase 2 results, combined with previously reported efficacy and safety data, underscore frexalimab’s potential to deliver meaningful improvements for MS patients.


Further Studies and Future Prospects

Sanofi has initiated global phase 3 studies of frexalimab in relapsing MS and nrSPMS. These studies aim to further evaluate frexalimab’s efficacy and safety, with a focus on delaying disability progression. The phase 2 study’s primary endpoint was the reduction in the number of new Gd+ T1 MRI brain lesions at week 12, with secondary endpoints including additional MRI-based efficacy measures, safety, tolerability, and pharmacokinetics.

Frexalimab (SAR441344) is positioned as a potentially first-in-class second-generation CD40L antibody. It is also being studied for other significant indications, such as systemic lupus erythematosus and Type 1 diabetes. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc.

Sanofi’s commitment to advancing precision medicine and providing life-changing treatment options is evident in their development of frexalimab. The company’s innovative approach aims to transform the practice of medicine by addressing both acute and chronic conditions, ultimately improving patient outcomes.

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Resource: Sanofi, June 28, 2024

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