Sanofi launched the BTK Inhibitor International Multi-Center Phase 3 trial in China

Sanofi has launched the primary progressive multiple sclerosis (PPMS) study of BTK inhibitor SAR442168 in China, a Phase 3, Randomized, Double-Blind, and International Multi-Center Phase 3 study comparing the efficacy and safety of SAR442168 and placebo among PPMS subjects.
, the drug has been positive in phase 2b clinical trials for patients with multiple sclerosis (MS).
screenshot Source: Reference: Reference 1. SAR442168 is an oral Bruton tyrosine kinase (BTK) inhibitor that crosses the blood-brain barrier.
BTK is important for the development and function of a variety of immune cells, including B lymphocytes and macrophages.
researchers believe that by inhibiting BTK, adaptive and congenital immune cells associated with neuroinvestation in the brain and spinal cord can be regulated.
2020, Sanofi submitted three clinical trial applications for SAR442168 in China.
these three applications were subsequently approved by CDE clinical trials for the treatment of non-relapsed secondary progressive multiple sclerosis (NRSPMS), relapsed multiple sclerosis (RMS), and primary progressive multiple sclerosis.
Screenshot Source: CDE Website According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Sanofi initiated a Phase 3, Randomized, Double-Blind Study (PERSEUS) comparing the efficacy and safety of SAR442168 with placebo in primary progressive multiple sclerosis subjects.
the study was led by Dr. Quan Chao, Deputy Director of Huashan Hospital affiliated with Fudan University, with the target number of 20 people in China and 990 internationally.
study focused on disability progress confirmed at six months, with a secondary endpoint of 3 months confirmed progression in disability, time at which confirmed disability improvement occurred, changes in the quality of life of multiple sclerosis, etc.
previously, SAR442168 had reached the primary and secondary end point in a Phase 2b clinical trial in patients with multiple sclerosis, and the drug candidate had reduced the number of new and enlarged Gd-T1 lesions in the patient's brain by 85%.
According to Sanofi's earlier press release, SAR442168 is expected to be the first disease-altering treatment to target the origin of brain injury in MS patients, and the company plans to launch four Phase 3 clinical trials for patients with resusced hairstyles and progressing MS.
note that SAR442168 is a BTK product developed by Principia Biopharma based on its proprietary Covalency technology platform.
the platform can design reversible co-price and irreversible co-priced small molecule inhibitors, resulting in higher selectivity, less off-target effect inhibitors.
2017, Sanofi established a partnership with Principia, which received a global exclusive license to develop and promote SAR442168 in multiple sclerosis and other central nervous system diseases.
look forward to the smooth progress of PHASE 3 clinical studies in China, bringing new treatment options to patients with multiple sclerosis at an early date.
。