Sanofi Launches Phase III Clinical Trial in China for Complement C1s Monoclonal Antibody Riliprubart in CIDP

On May 29, according to the Drug Clinical Trial Registration and Information Disclosure Platform, Sanofi registered a Phase III clinical trial for Riliprubart Injection targeting chronic inflammatory demyelinating polyradiculoneuropathy. Public data shows that Riliprubart (BIVV020/SAR445088) is a complement C1s monoclonal antibody.

Source of the image: Drug Clinical Trial Registration and Information Disclosure Platform

For CIDP
Phase III trial ongoing overseas

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is primarily caused by immune antibody-mediated reactions. It is a relatively rare and severe sensory-motor peripheral neuropathy, with a prevalence of approximately 1/10,000 to 9/10,000. CIDP presents with serious symptoms including quadriplegia, respiratory failure, and even death. Additionally, it may involve endoneurial interstitial and perivascular inflammatory T-cell and macrophage infiltration.

Complement C1s, as one of the key components in the complement system, plays a crucial role in inflammatory responses and pathogen clearance. The C1s protein is involved in initiating the complement cascade. Relevant studies indicate that excessive activation of the complement system may lead to tissue damage and disease onset; therefore, blocking the function of the C1s protein holds promise for treating various autoimmune diseases.

Riliprubart is a complement C1s monoclonal antibody developed by Sanofi. It can reduce the inflammatory response in CIDP patients by preventing the overactivation of the complement system. In November 2023, Riliprubart was included by the CDE as a breakthrough therapy for the treatment of CIDP.

Source of the image: CDE official website

Currently, Sanofi is conducting Phase III clinical trials overseas. In March this year, Sanofi presented the Phase II study data of Riliprubart for the treatment of CIDP at the American Academy of Neurology (AAN) Annual Meeting. The trial recently registered by Sanofi in China is a Phase III, double-blind, placebo-controlled study evaluating the efficacy and safety of Riliprubart in subjects with refractory CIDP.

Focus on the autoimmune field
Accelerate Pipeline Expansion

Immunology and Inflammation (I&I) are key research areas for Sanofi, with several products showing great potential, including the "blockbuster" Dupixent and the world's first anti-IL-6 monoclonal antibody "Kevzara".

In addition to Riliprubart, Sanofi has another approved complement C1s monoclonal antibody, "Sutimlimab," already on the market. Moreover, several projects in Sanofi's I&I pipeline have recently made significant progress.

Sutimlimab

Sutimlimab was approved for marketing by the U.S. FDA in February 2022 to reduce the need for red blood cell transfusions due to hemolysis in patients with cold agglutinin disease (CAD). Similar to Riliprubart's mechanism of action, Sutimlimab exerts its hemolysis-inhibiting effect by blocking the function of the C1s protein in the classical complement pathway. As the first complement C1s antibody approved by the FDA for the treatment of CAD, Sutimlimab achieved sales of 72 million euros in its first full year on the market, representing a year-on-year increase of 240.9%.

Rilzabrutinib

Rilzabrutinib is a BTK inhibitor currently being studied for the treatment of autoimmune diseases such as pemphigus, immune thrombocytopenia (ITP), and chronic spontaneous urticaria (CSU). Recently, Sanofi announced positive results from a Phase II study of Rilzabrutinib, showing that the drug reduced the number of loss of asthma control (LOAC) events in patients with moderate to severe asthma while improving uncontrolled symptoms.

Frexalimab

Frexalimab is a CD40L monoclonal antibody that was approved for clinical trials in China in April 2024. Recently, Sanofi registered a clinical trial for this drug on the Drug Clinical Trial Registration and Information Disclosure Platform, targeting adult subjects with non-relapsing secondary progressive multiple sclerosis (nrSPMS). According to a study published in The New England Journal of Medicine in February 2024, Frexalimab significantly slowed disease activity in patients with relapsing multiple sclerosis.

In addition, there are several drugs in Sanofi's I&I pipeline that are advancing in clinical research, including the OX40L-targeting monoclonal antibody Amlitelimab and the IL-13/TSLP dual blocker Lunsekimig.

Conclusion

Based on the large market scale of autoimmune diseases and unmet clinical needs, by accelerating the research progress of pipelines in areas such as autoimmune diseases, Sanofi is expected to achieve further innovative results.

Editor: Muyan

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