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Sanofi communicates positive results from trial of frexalimab for multiple sclerosis (MS)

Sanofi, a French pharmaceutical company, is developing frexalimab under an exclusive license from ImmuNext. Positive Phase II trial results were recently announced for this investigational anti-CD40L antibody, showing promise in reducing brain lesions in relapsing multiple sclerosis (MS) patients without lymphocyte depletion.

In the trial's Part A, high and low doses of frexalimab were tested against a placebo over 12 weeks. Reduction in new gadolinium-enhancing (GdE) T1 MRI brain lesions at week 12 was the primary endpoint. Both doses significantly reduced lesions compared to placebo, with sustained effects observed up to week 24, especially in the high-dose arm.

Frexalimab was well-tolerated, with Covid-19 and headache being the most common adverse events. Sanofi has initiated Phase III trials for non-relapsing secondary progressive MS and relapsing MS. Additionally, Sanofi Vaccines partnered with Medidata for electronic clinical outcome assessment (eCOA) in vaccine studies.