Bristol-Myers Squibb (BMS) recently announced that the key phase 3 study POETYK PSO-2, which evaluates a new anti-inflammatory drug deucravacitinib (BMS-986165) in the treatment of moderate to severe plaque psoriasis, has reached a common primary endpoint and multiple key secondary points end. Deucravacitinib is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical research evaluating the treatment of various immune-mediated diseases.
The POETYK PSO-2 study evaluated the efficacy and safety of deucravacitinib (6 mg once a day) in patients with moderate to severe plaque psoriasis, and compared it with placebo and Otezla (apremilast, 30 mg, twice a day) . The results showed that the study reached the common primary endpoint: after 16 weeks of treatment, compared with the placebo group, a higher proportion of patients in the deucravacitinib treatment group improved their psoriasis area and severity index relative to baseline by at least 75% (PASI75), static The Physician's Global Assessment (sPGA) score is complete or almost complete removal of the skin lesions (sPGA 0/1).
In addition, the study reached a number of key secondary endpoints, including: in the proportion of patients achieving PASI75 remission and sPGA 0/1 at week 16, the deucravacitinib treatment group was better than the Otezla treatment group. In this study, the overall safety of deucravacitinib is consistent with the previously reported results and is consistent with the mechanism of action of deucravacitinib.
POETYK PSO-2 is the second of two global phase 3 studies. These two studies have shown that in patients with moderate to severe plaque psoriasis, once-daily deucravacitinib is superior to placebo and Otezla. The positive results of the first pivotal phase 3 study, POETYK PSO-1, were announced in November 2020. The company and key researchers will complete a comprehensive evaluation of the POETYK PSO-2 research data and share detailed results at future medical conferences.
Samit Hirawat, MD, Executive Vice President and Chief Medical Officer of Bristol-Myers Squibb Global Drug Development, said: "Deucravacitinib is a potential new molecule. The encouraging data we have seen so far indicate that deucravactinib has the potential to become a psoriasis. An important oral treatment option for patients. We look forward to discussing the results of the POETYK PSO-1 and POETYK PSO-2 registration studies with regulatory authorities, with the goal of providing this new treatment to patients with this serious disease as soon as possible."
Deucravacitinib chemical structure
Deucravacitinib is a new type of oral selective TYK2 inhibitor with a unique mechanism of action different from other kinase inhibitors. TYK2 is an intracellular signal kinase that mediates the signal transduction of IL-23, IL-12, and type I IFN. These cytokines are natural cytokines involved in inflammation and immune response.
Currently, deucravacitinib is being evaluated for the treatment of a wide range of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol-Myers Squibb is conducting three other Phase 3 studies on deucravacitinib: POETYK PSO-3 (NCT04167462), POETYK PSO-4 (NCT03924427), POETYK PSO-LTE (NCT04036435) ).