Railway Workers' Union (Austria)

Press Release: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS

Retrieved on: 
Thursday, February 15, 2024
Week, Railway Workers' Union (Austria), Headache, Consortium, Multiple sclerosis, Sanofi, COVID-19, AFL, Patient, Plasma, Medical imaging

Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.

Key Points: 
  • Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.
  • Frexalimab is Sanofi’s novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion.
  • “These published Phase 2 results for frexalimab represent important data in not only the potential treatment of MS but to the broader MS community.
  • Sanofi has initiated Phase 3 clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS.

Press Release: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab show significantly reduced disease activity in relapsing multiple sclerosis

Retrieved on: 
Wednesday, May 31, 2023
Railway Workers' Union (Austria), Macrophage, Barts and The London School of Medicine and Dentistry, Week, Disability, Research, Multiple sclerosis, CMSC, Queen Mary University of London, MS, St. Bartholomew's, Patient, Sanofi, Dentistry, Pivotal, CD40L, B cell, Blizard Building, Pharmaceutical industry, Vaccine, Neurology

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

Key Points: 
  • 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
    Paris, May 31 2023.
  • New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis (MS).
  • 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.
  • A substantial unmet need remains in MS for highly effective and well-tolerated treatment options that provide sustainable control of disease activity and disability progression, while minimizing risks.