The new anti-inflammatory drug TYK2 inhibitor BMS-986165 treats moderate to severe plaque psoriasis Phase II clinical:

U.S. pharmaceutical giant BMS recently released positive data on the experimental anti-inflammatory drug BMS-986165 for the treatment of moderate to severe plaque psoriasis Phase II clinical study IM011-011.
The study was conducted in a multi-center, randomized, double-blind, placebo-controlled, parallel group study in adult patients with moderate to severe plaque-type psoriasis to assess the clinical efficacy and safety of BMS-986165. A total of 267 patients were included in the study, which were assigned to five BMS-986165 programme groups in a ratio of 1:1:1:1:1:1 (3mg QOD, n=44) and 3mg QD (daily) 3mg, n=44, 3mg BID (2 times a day 3mg, n=45?, 6mg QD (2 mg per day, n=45?, 12mg QD (12mg per day, n=44)) or placebo group (n=45). The main endpoint is the proportion of patients who achieved PASI75 in week 12 of treatment, with key secondary endpoints including PASI90, PASI100, and Dermatological Quality of Life Index (DLQI).
results showed that in the 12th week of treatment, the proportion of patients in the 3mg BID and higher dose BMS-986165 treatment group who achieved PASI75 was 67%-75%, compared with 7% in the placebo group. Specifically, the proportion of patients achieving PASI75: 7% in the placebo group, 9% in the 3mgQOD (p=0.49), 39% in the 3mgQD (p<0.001), and 3mgBID 69% (p<0.001), 67% (p<0.001) and 75% (p<0.001). The observed efficacy was independent of whether the patient had previously received biological therapy.
secondary endpoints include PASI90 (2 per cent, 7 per cent, 16 per cent, 44 per cent, 44 per cent, 43 per cent) and PASI100 (0 per cent, 2 per cent, 0 per cent, 9 per cent, 18 per cent, 25 per cent, respectively). In the static physician comprehensive assessment (sPGA) score of 0 (clear) or 1 (micro-disease), the proportion of patients in the 3mgBID and higher dose BMS-986165 treatment group was 64%-76%, compared to 7% in the placebo group. The DLQI score was 0 or 1, with 42%, 60% and 64% of the 3mgBID, 6mgBID and 12mgQD treatment groups, respectively, and 4% in the placebo group.
safety, there were 3 serious adverse events in the BMS-986165 treatment group and 2 cases in the placebo group. The maximum dose group of BMS-986165 (6mgBID and 12mgQD) did not have serious adverse events. The rate of adverse events in the BMS-986165 treatment group was 55%-80%, compared with 51% in the placebo group. The most common adverse reactions include nasopharyngitis, headache, diarrhea, nausea and upper respiratory tract infections.Mary Beth Harler, director of innovative drug research and development at
Centennia, said that at present, moderate to severe plaque psoriasis is still undertreated and many patients are still suffering from inadequate disease control, and there is a significant medical need for effective, convenient and life-impact treatment options. BMS-986165 is a new type of oral selective TYK2 inhibitor, which has a unique mechanism of action that promises to provide a promising oral option to help patients effectively control their psoriasis.
TYK2 is an intracellular signaling kinase that mediates cytokine-driven immune and inflammatory signaling paths that play a vital role in the chronic inflammatory cycle of immuno-mediated diseases. TYK2 mediates IL-23, IL-12 signal conduction, and type I IFN-driven responses, but does not mediate cytokine responses mediated by other kinases, such as IL-6, hematogic growth factors, and IL-2 families. TYK2 signaling is involved in the pathophysiology of a variety of immuno-mediated diseases, including psoriasis, lupus, and inflammatory bowel disease.
BMS-986165 is a new, oral and selective TYK2 inhibitor with a unique mechanism of action different from other kinase inhibitors. Currently, a Phase III clinical project to evaluate the drug for plaque-type psoriasis is recruiting patients to evaluate the drug's treatment of other immuno-mediated diseases such as lupus and Crohn's disease in Phase II clinically. (Bio Valley)