Sanofi Submits Clinical Trial Application in China for Frexalimab, a Novel Anti-CD40L Monoclonal Antibody, for Multiple Sclerosis and Type 1 Diabetes

Feb 04, 2024 12:23 CST Updated 12:23

Sanofi

Pharmaceutical R&D Developer

▎WuXi AppTec Content Team Report

On February 2, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Sanofi（Sanofi）Filed for a Class 1 new drugThe clinical trial application for frexalimab injection has been accepted. According to publicly available information,ThisIt is a monoclonal antibody targeting CD40L.Previously reached the primary endpoint in a Phase 2 clinical study for the treatment of multiple sclerosis and is currently being conducted overseas.TreatmentMultiple SclerosisPhase 3 Clinical Trials and TreatmentType 1 DiabetesPhase 2b clinical trial.

Screenshot source:CDE Official Website

CD40LThrough its interaction with the receptor CD40, it plays a crucial role in regulating the interactions between T cells and other immune cells (especially B cells and antigen-presenting cells), thereby influencing some important functions related to autoimmune diseases.

Frexalimab (SAR441344) is a novel monoclonal antibody,Sanofi Obtains Exclusive License from ImmuNext to Develop the Product.FrexalimabIs consideredCapable of blocking the co-stimulatory CD40/CD40L cellular pathway essential for the activation and function of adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cells., without causing lymphocyte depletion.Clinical and pathological evidence suggests that the CD40/CD40L pathway plays a crucial role in the onset and progression of multiple sclerosis, potentially relating to peripheral immune tolerance.

Screenshot source: Reference [2]

In addition, by blocking the CD40 signaling pathway,Frexalimab also has the potential to protect pancreatic β-cells and alter the disease progression of type 1 diabetes.。For a long time, scientists have believed that Type 1 diabetes is an autoimmune disease., is due to the killing by cytotoxic CD8 T cellsResponsible for insulin productionThePancreatic β cells, leading to lifelong dependence on insulin therapy for patients. Frexalimab minimizes T-cell activation and protects against further β-cell loss by blocking a key amplification step between T cells and B cells.

Screenshot source:References[2]

According toClinicalTrialsAccording to the official website, Sanofi has initiated two Phase III clinical trials for frexalimab, respectively for the treatment ofAdultNon-relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)AndRelapsing Multiple Sclerosis (RMS).At the same time, a phase 2 clinical study has been initiated to evaluate its effect onAdults and Adolescents with Type 1 DiabetesEfficacy and safety.

In May 2023, Sanofi presented the results of frexalimab for the treatment of relapsing multiple sclerosis at the 2023 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).Phase 2ClinicalTestResults.The primary endpoint of the trial was the reduction in the number of new GdE T1 high-signal magnetic resonance imaging (MRI) brain lesions after 12 weeks of treatment. The trial met its primary endpoint.Compared with placebo, higher and lower doses of frexalimab respectivelyReduced the number of newly emerging GdE T1 lesions by 89% and 79%.In addition, both groups receiving frexalimab treatment showed a reduction in the number of new or enlarging T2 lesions and the total number of GdE T1 lesions. At week 24, 96% of patients receiving the higher dose of frexalimab had no new GdE T1 lesions.

Multiple sclerosis is a chronic disease with more than 2.8 million patients worldwide.When MS occurs, the immune system abnormally attacks the myelin (which insulates and supports the axons of nerve cells) of nerve cells in the central nervous system (brain, spinal cord, and optic nerves), leading to inflammation and damage.This damage can lead to a series of symptoms, including muscle weakness, fatigue, and vision difficulties, which may eventually result in disability.Most MS patients first experience symptoms between the ages of 20 and 40, making the disease a leading cause of non-traumatic disability in young adults.

Diabetes is divided into Type 1 and Type 2. Type 1 diabetes accounts for about 10% of cases, with patients typically developing the condition during childhood or adolescence.T1D leads to reduced insulin secretion and impaired blood glucose control, ultimately resulting in hyperglycemia. Hyperglycemia can cause diabetic ketoacidosis, and over time, may lead to complications such as nephropathy/renal failure, eye diseases (including blindness), heart disease, stroke, nerve damage, and even death.

Hope Sanofi's this anti-CD40L monoclonal antibody subsequent clinical research progress is proceeding smoothly, bringing new treatment options to patients as soon as possible.

References:

[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Feb 2, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Sanofi R&D day. Retrieved December 7, 2023, from https://www.sanofi.com/assets/dotcom/content-app/events/investor-presentation/2023/r-and-d-day-2023/Presentation.pdf

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