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February 06, 2021 // -- BMS recently announced that the evaluation of the new anti-inflammatory drug deucravacitinib (BMS-986165) for the treatment of moderate to severe plaque psoriasis key Phase 3 study POETYK PSO-2 has reached a common primary endpoint and several key secondary endpoints.
deucravacitinib is the first and only new, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies to evaluate the treatment of a variety of immunometic diseases.
POETYK PSO-2 study evaluated the efficacy and safety of deucravacitinib (6 mg once daily) in treating patients with moderate to severe plaque-type psoriasis patients and compared it with placebo and Otezla (apremilast, 30 mg, 2 times a day).
results showed that the study reached a common primary endpoint: after 16 weeks of treatment, a higher proportion of patients in the deucavacitinib treatment group had psoriasis area and severity index improvement of at least 75% relative to the baseline (PASI75), and the static physician overall assessment (sPGA) score was completely or almost completely cleared of dermatical damage (sPGA 0/1).
addition, the study reached several key secondary endpoints, including that the deucravacitinib treatment group outperformed the Otezla treatment group in terms of patient ratios reaching PASI75 remission and sPGA 0/1 in week 16.
study, the overall security of deucravacitinib was consistent with previously reported results and with the mechanism of function of ducravacitinib.
POETYK PSO-2 was the second of two global Phase 3 studies that showed that in patients with moderate to severe plaque psoriasis, once-a-day deucravacitinib was superior to placebo and Otezla.
positive results from the first key Phase 3 study, POETYK PSO-1, were announced in November 2020.
the company and leading researchers will complete a comprehensive assessment of POETYK PSO-2 research data and share detailed results at future medical conferences. "Deucravacitinib is a potential new molecule, and the encouraging data we've seen so far suggest that deucravactinib has the potential to be an important oral treatment option for patients with psoriasis," said Dr. Samit Hirawat, M.D., Executive Vice President and Chief Medical Officer, Global Drug Development,
Centennamus.
look forward to discussing with regulatory authorities the results of the POETYK PSO-1 and POETYK PSO-2 registration studies with a view to providing this new treatment to patients with this serious disease as soon as possible.
"deucravacitinib chemical structure (Photo: genome.jp) deucravacitinib is a new type of oral selective TYK2 inhibitor with a unique mechanism of action unlike other kinase inhibitors.
TYK2 is an intracellular signal kinase that mediates the signaling of IL-23, IL-12, and I-type IFN, which are natural cytokines involved in inflammation and immune response.
, deucravacitinib is being evaluated for the treatment of a wide range of immunomedeotive diseases, including psoriasis, psoriasis arthritis, lupus and inflammatory bowel disease.
addition to POETYK PSO-1 and POETYK PSO-2, Shishi Meishiguibo is conducting three other Phase 3 studies on deucravacitinib: POETYK PSO-3 (NCT04167462), POETYK PSO-4 (NCT03924427), POETYK PSO-LTE (NCT04036435).
Origin: Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Show Show Superiority of Deucravacitinib Compared to Placebo and Otezla? (apremilast)