Sanofi’s drug frexalimab reduces disease activity in relapsing MS


New data, presented in a breakthrough session at the Consortium of Multiple Sclerosis Centers (CMSC) 2023 annual meeting, show that frexalimab, Sanofi’s new second-generation investigative anti-CD40L antibody, with a unique mechanism of action, significantly reduces disease activity in trials. phase 2 patients with relapsed multiple sclerosis (MS).

After 12 weeks of therapy, the number of new gadolinium-enhancing T1 lesions (GdE) was reduced by 89% and 79% in the high- and low-dose treatment groups, respectively, compared to placebo, meeting the primary end point of the study.

A substantial unmet need remains in MS for highly effective and well-tolerated treatment options that provide ongoing control of disease activity and development of disability, while minimizing risks. As the first second-generation anti-CD40L antibody to demonstrate efficacy in MS, frexalimab is thought to block the costimulatory CD40/CD40L cellular pathway required for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function. , without lymphocyte depletion.

Erik Wallström, global head of neurology development at Sanofi said: “Building on our 20 years of research and development in multiple sclerosis, we are committed to growing our robust suite of MS therapies by exploring different treatment approaches with unique MOAs that have the potential to slow or stop disability, which remains one of the greatest unmet medical needs in multiple sclerosis today.”

Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, added: “Frexalimab has a unique mechanism of action, blocking the costimulatory CD40/CD40L pathway which is thought to regulate both adaptive and activation and function. innate immune cells – a pathway that is critical in the pathogenesis of MS. We are very pleased with the results achieved with frexalimab in only three months, which demonstrates that CD40L inhibition rapidly controls MS disease activity without lymphocyte depletion.”

Important trials in MS are planned to be launched in 2024.

About Sanofi’s phase 2 study

The phase 2 study was a randomized, double-blind, placebo-controlled trial evaluating frexalimab in patients with relapsed MS. In the trial, 129 patients with relapsed MS were randomized to receive a higher or lower dose of frexalimab or a matched placebo for 12 weeks (Section A). After week 12, patients receiving the placebo switched to their respective frexalimab arms and entered open-label Part B, which is currently ongoing. The primary end point was a 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 study, both groups that received higher or lower doses of frexalimab experienced a significant reduction in new GdE T1-hyperintense lesions after 12 weeks of treatment. At Week 12, high and low doses of frexalimab significantly reduced the number of new GdE T1 lesions by 89% and 79%, respectively, compared with placebo (combined dose group). In addition, both groups treated with frexalimab showed reductions in new or enlarged T2 lesions and total GdE T1 lesions. At Week 24, 96% of participants in the high-dose frexalimab group were free of new GdE T1 lesions. Initial effects (Week 12) on MSIS-29 physical impact score (patient reported outcome) and plasma neurofilament light chain (NfL) levels will also be reported.

Frexalimab was well tolerated, and 97% of patients completed Part A and progressed to open label Part B. The most common side effects (≥4%) in the group treated with frexalimab were COVID-19 and headaches.

About frexalimab

Frexalimab (SAR441344) is a novel monoclonal antibody that is thought to block the costimulatory CD40/CD40L cellular pathway required for activation and function of adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cells, without lymphocyte depletion. Sanofi is developing SAR441344 under an exclusive license from ImmuNext Inc. Frexalimab is an investigative product, and its safety and efficacy have not been reviewed by any regulatory authority.


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