Frexalimab, a new experimental anti-CD40L antibody developed by Sanofi, has shown very promising results, offering a reduction of up to 89% in the appearance of new brain lesions.
- The Frexalimab treatment showed promising results in a phase II trial.
- High-dose Frexalimab significantly reduced disease activity, with an 89% reduction in new brain lesions.
- Phase III trials are now underway.
Multiple sclerosis is an autoimmune disease that causes the immune system to attack myelin, the protective sheath of neurons that facilitates the passage of nerve impulses. This pathology causes motor, sensory, cognitive or even visual disorders. Affecting 110,000 people in France, it is the leading cause of non-traumatic disability among young adults.
A new hope opens up for these patients. The Sanofi laboratory revealed in a press release that frexalimab, a new second-generation experimental anti-CD40L antibody developed by its teams, obtained positive results. This medication significantly slowed disease activity in people with relapsing-remitting multiple sclerosis (MS).
Data from the phase II trials have been published in the journal New England Journal of Medicine on February 15.
MS: a reduction in new lesions
In this experiment, researchers brought together 129 adults with relapsing-remitting MS. They received either a high dose of the anti-CD40L antibody frexalimab (1,200 mg), a low dose (300 mg), or a placebo also at a high dose or a low dose.
After 12 weeks of treatment, the team noticed a reduction in the appearance of new T1 lesions enhanced by gadolinium (contrast method on MRI) for the high dose and low dose groups of 89% and 79%. %, respectively. The total number of lesions had fallen by 88% and by 80%.
Concerning the lesions observed (new or increased in volume) with the T2 contrast method, a reduction of 92% and 86% was recorded.
“These published phase II results for frexalimab represent important data not only for the potential treatment of multiple sclerosis, but also for the entire multiple sclerosis community. It should be noted that at the week 12, both doses of frexalimab studied produced a pronounced reduction in new lesions – a standard measure of inflammatory activity in multiple sclerosis – and their effect was well maintained over time, especially in the group of patients treated with the highest dose of frexalimab. In fact, 96% of them had no new active lesions at week 24 of treatment.specifies Dr Patrick Vermersch of the University of Lille in a communicated.
Frexalimab: phase III trials already underway
Frexalimab would also improve several indicators of disease progression: MSIS-29 (MS physical impact score measured using the MS Physical Impact Scale, based on patient-reported results), concentrations plasma levels of neurofilament light chain (NfL) – a biomarker of neuroaxonal damage and MS activity – as well as plasma concentrations of CXCL13, a biomarker of inflammatory activity.
The treatment was otherwise well tolerated. 97% of participants took it during the study. The most common adverse events (≥5%) observed in both groups treated with frexalimab were Covid-19 (9.8%) and headache (2.0% and 5.8% respectively).
Faced with these promising results, phase III trials (comparative trials with standard treatments) in the treatment of relapsing-remitting multiple sclerosis and non-relapsing secondary progressive multiple sclerosis were subsequently launched.