The company Sanofi has published the results of a clinical phase II trials of an experimental drug SAR442168 for the treatment of multiple sclerosis, according to FierceBiotech. The collected data was so convincing that the pharmaceutical manufacturer has announced the beginning of four phase III studies.
According to the KEY phase II, application SAR442168 reduce the formation of new lesions by 85%. However, critics point to the shortcomings of the study design. In phase II CI was attended by 130 patients with relapsing form of multiple sclerosis, the participants were divided into 8 groups. Each group received one of four doses SAR442168 for 12 weeks. Therapy in half of the groups were started after the use of placebo for 4 weeks in the second half of groups a placebo was applied after completion of the treatment period.
In February of this year, Sanofi announced the achievement of the primary endpoint of the study, but the results have been published only now. So, SAR442168 in the highest dose was reduced by 85% kontroliruemykh the formation of new gadolinium lesions on T1-weighted images. Also been shown a decline of 89% in the number of new or enlarged lesions on T2-weighted images.
SAR442168 is a tyrosine kinase inhibitor, the rights to its development, Sanofi received the American biotechnology company Principia Biopharma. The amount of the transaction in the case of registration of the drug will amount to 765 million dollars.