▎Edited by the WuXi AppTec content teamOn March 1, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Sanofi's Class 1 new drug SAR441566 has been approved for clinical trials, intended for development to treatModerate to Severe Rheumatoid Arthritis (RA)AndModerate to Severe Plaque PsoriasisTwo indications.Public information shows that SAR441566 is aOral TNFα Inhibitor。
Screenshot source: CDE official website
Tumor Necrosis Factor (TNF) is a pleiotropic cytokine that belongs to the trimeric protein family and possesses both pro-inflammatory and immunomodulatory functions. As a key mediator in autoimmune diseases, uncontrolled production of TNF is associated with the development of chronic inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, psoriasis, and ankylosing spondylitis.TNF through two separate receptors——Tumor Necrosis Factor Receptor 1 and 2（TNFR1 andTNFR2) Deliver signals,There are significant differences in the cellular localization of these receptors.，TNFR1 is widely expressed, while TNFR2 expression is limited to immune cells.At physiological concentrations, soluble TNF can activate TNFR1 but not TNFR2.Membrane-bound TNF can activate both receptors.According to publicly available information from Sanofi, SAR441566 is a member of the company's next-generation oral medications, acting as an inhibitor of the TNFR1 signaling pathway.These drugs can target disease-related core pathways and possess both the convenience of oral administration and the efficacy of antibodies.。
▲Sanofi's Next-Generation Oral Drug (Image Source: Sanofi Official Website)
Public information from Sanofi shows,SAR441566 canTwisted Soluble TNFαTrimeric conformation, disrupting TNFR1 signaling, therebyInhibition of TNF function,But it does not affect TNFα bound to the cell membrane (i.e.,TNFR2 signaling pathway)Signal transduction, therebyReduce the risk of infection and improve efficacy. This product is expected to provide a more convenient option for patients with chronic autoimmune diseases.OralTreatment options, with efficacy comparable to biologics targeting TNF.▲Introduction to SAR441566 (Source: Sanofi's official website)In the Phase 1b clinical trial for the treatment of psoriasis, SAR441566 demonstrated good safety and tolerability while improving symptoms. According toClinicalTrialsPlatform information: SAR441566 is currently in Phase 2 clinical trials for the treatment of psoriasis and rheumatoid arthritis.Rheumatoid ArthritisIt is a chronic, progressive autoimmune disease that, if not treated in time, can lead to disability and systemic complications, including pulmonary, cardiovascular, dermatological, and ophthalmic diseases, seriously affecting the patient's quality of life and physical health.PsoriasisIt is a chronic, recurrent, inflammatory, and systemic disease induced by the interaction of genetic and environmental factors, mediated by the immune system. Clinically, it presents as scaly erythematous patches or plaques, with localized or widespread distribution. Psoriasis can be associated with systemic diseases, significantly affecting the patient's quality of life.We look forward to the early successful development of Sanofi's drug, benefiting a large number of patients.References:
[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Mar 1, 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] Vugler
A, O'Connell J, Nguyen MA, et al. (2022) An orally available small molecule
that targets soluble TNF to deliver anti-TNF biologic-like efficacy in
rheumatoid arthritis. Front Pharmacol. https://pubmed.ncbi.nlm.nih.gov/36467083/
[3] 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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