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Bristol Myers Squibb have announced phase 3 trial evaluating the efficacy and safety of deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor.
Source: bms.com
Quote:
Bristol Myers Squibb today announced positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-1 evaluated 6 mg of deucravacitinib once daily and met both co-primary endpoints versus placebo, with more patients achieving Psoriasis Area and Severity Index (PASI) 75, defined as at least a 75 percent improvement in PASI, and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.
The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla® (apremilast) in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported Phase 2 results.
“With limited oral therapeutic options available for psoriasis, there remains a significant need for safe and effective oral therapies. This makes the positive topline results for deucravacitinib in the POETYK PSO-1 trial exciting for the psoriasis community,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “These findings indicate deucravacitinib has the potential to be a new treatment option for people living with psoriasis and may provide clinically meaningful improvements with the convenience of oral administration.”
The company and principal investigators will complete a full evaluation of the POETYK PSO-1 data and share the detailed results at a future medical meeting. POETYK PSO-1 is the first of two global Phase 3 studies designed to evaluate safety and efficacy of deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis. Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021. In addition to psoriasis, deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, and the company will present results from its Phase 2 trial in psoriatic arthritis at the American College of Rheumatology (ACR) Convergence 2020, taking place virtually November 5-9, 2020.
“We are encouraged by the efficacy and safety profile observed in the POETYK PSO-1 study, which supports the strong potential we see for deucravacitinib, our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “We recognize there is a significant unmet need for new therapeutic options for people with immune-mediated diseases, such as psoriasis, and are committed to pursuing potential new medicines that will give physicians additional choices to effectively treat and manage their patients.”
Source: bms.com