Phase III POETYK PSO-1 trial of BMS 986165 meets endpoints in plaque psoriasis.- BMS

Bristol Myers Squibb announced positive results from POETYK PSO-1, the first pivotal Phase III trial evaluating BMS-986165 (deucravacitinib), 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 II results. 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. Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021.