Clinical Trials

Sanofi announces positive phase 2 data for MS drug frexalimab

French pharmaceutical and healthcare company Sanofi has announced positive trial data from its phase 2 clinical study into its relapsing multiple sclerosis (MS) drug.

Frexalimab (SAR441344) is a second-generation investigational monoclonal anti-CD4OL antibody. It is believed to block the co-stimulatory CD40/CD40L cellular pathway necessary for adaptive (T- and B-cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion.

The phase 2 study was a randomised, double-blind, placebo-controlled trial, which evaluated the drug in patients with relapsing MS. In part A, there were 129 participants, which were randomised to receive either higher or lower doses of frexalimab or the matching placebo for 12 weeks. Open-label part 2, which is ongoing, saw the patients receiving the placebo switch to the respective frexalimab arm after 12 weeks.

The primary endpoint was indicated as the reduction in the number of new GdE T1-hyperintense MRI brain lesions after 12 weeks of treatment – at week 12, patients achieved an 89% decrease in the higher dose group and 79% in the lower dose. Both groups also showed reductions in new or enlarging T2-lesions and total GdE T1-lesions.

Erik Wallström MD PhD, global head of Neurology Development at Sanofi, said: “Building on our 20 years of research and development in MS, we are committed to growing our robust pipeline of MS therapies by exploring multiple treatment approaches with unique mechanisms of action (MOAs) that have the potential to slow or halt disability, which remains one of the greatest unmet medical needs in MS today.” Gavin Giovannoni MD PhD FCP

FRCP FRCPath, chair of Neurology at Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London commented: “Frexalimab has a unique mechanism of action, blocking the CD40/CD40L co-stimulatory pathway thought to regulate both adaptive and innate immune cell activation and function – apathway that is pivotal in the pathogenesis of MS. We are thrilled with the results achieved with frexalimab in just three months, which shows that CD40L inhibition rapidly controls MS disease activity without lymphocyte depletion.”