Sanofi Launches Phase III Clinical Trial of Anti-CD40L Monoclonal Antibody Frexalimab (SAR441344) in China for Non-Relapsing Secondary Progressive Multiple Sclerosis

On May 13, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Sanofi's anti-CD40L monoclonal antibody SAR441344 (frexalimab) had initiated a Phase III clinical trial in China. The product entered the Phase III stage for the first time in December 2023.

This study is a randomized, double-blind, placebo-controlled clinical trial planning to recruit 20 subjects in China. It aims to evaluate the safety and efficacy of SAR441344 in adult patients with non-relapsing secondary progressive multiple sclerosis. The primary endpoint is the time to confirmed disability progression (cCDP) as measured by a composite endpoint within 6 months.

SAR441344 can block the CD40/CD40L co-stimulatory pathway, which is essential for the activation and function of adaptive immune cells (T/B cells) and innate immune cells (macrophages and dendritic cells), without depleting lymphocytes, thereby achieving the goal of treating acute and chronic neuroinflammation in multiple sclerosis. The development progress of this product is in the first tier in the CD40L field.Expected to become the first CD40L-targeted drug in this disease area.

Later-stage CD40L-targeting drugs under research

In the Phase II study, SAR441344 reduced the area of new gadolinium-enhancing T1 brain lesions in MS patients by 89%. If the Phase III study is successfully completed, Sanofi plans to2025Submission of SAR441344 for the treatment of multiple sclerosis.

Besides, Sanofi is also exploring new avenues for the drug inProtecting Pancreatic β-Cell Function in Patients with Type 1 DiabetesThe potential on, seems to have the intention of combining it with teplizumab (brand name: Tzield) which is used to delay the progression of type 1 diabetes.

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