Phase 2 Results: Frexalimab Shows Promising Long-term Efficacy in MS

A recent clinical trial has shown promising results for a new treatment for multiple sclerosis (MS). The drug, frexalimab, developed by Sanofi, has demonstrated a significant reduction in disease activity and a high safety profile in patients with relapsing MS after 48 weeks of treatment. The findings were presented at the American Academy of Neurology's annual meeting in Denver, Colorado.
The study involved 129 participants who were given either a high or low dose of frexalimab or a placebo for the initial 12-week period. After this, those on the placebo were switched to one of the frexalimab treatment arms, and the study continued for a total of 48 weeks. The results showed that 96% of those on the high dose and 87% on the low dose had no new Gd+ T1 lesions, a type of lesion associated with MS. Additionally, the annualized relapse rate was extremely low at 0.04 for those on the high dose.
Dr. Patrick Vermersch of the University of Lille, who was involved in the study, stated that the data indicates that frexalimab could be a highly effective therapy for relapsing MS. The drug works by targeting the CD40L pathway, which is crucial for the activation of immune cells involved in MS.
Erik Wallström, Global Head of Neurology Development at Sanofi, highlighted the innovative nature of frexalimab, noting that it represents a new class of treatment for MS. He emphasized the company's commitment to addressing the full range of neuroinflammation and neurodegeneration to improve the lives of those living with MS.
The drug was generally well-tolerated, with the most common side effects being nasopharyngitis, headache, and COVID-19, affecting around 11% of patients. The phase 2 study was a randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of frexalimab, with the primary endpoint being the reduction in new Gd+ T1 MRI brain lesions at 12 weeks.
Frexalimab is a second-generation anti-CD40L antibody that has the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion. Sanofi is currently conducting phase 3 clinical studies for MS and phase 2 studies for other indications, including immunology and Type 1 Diabetes.
Sanofi is a global healthcare company focused on improving lives through science. They provide life-changing treatments and vaccines to millions worldwide and prioritize sustainability and social responsibility in their operations. The company is listed on both the EURONEXT and NASDAQ stock exchanges.