Bristol Myers Squibb: Positive Topline Results Pivotal Phase 3 Psoriasis Study of Deucravacitinib

Bristol Myers Squibb shared positive results from POETYK PSO-2, the second pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-2 evaluated deucravacitinib 6mg once daily and met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI 75), defined as at least a 75 percent improvement of baseline 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 6mg once daily was superior to apremilast in the proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in POETYK PSO-2 remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib.

Bruce Strober, MD, PhD, Clinical Professor of dermatology at Yale University School of Medicine and Central Connecticut Dermatology, commented, “I am excited to see that the results from this second pivotal trial further support the promising efficacy and safety profile of deucravacitinib. This represents an important step for the over 100 million people living with psoriasis worldwide, many of whom remain undertreated and are in need of new, effective oral therapies.”

POETYK PSO-2 is the second of two global Phase 3 studies demonstrating superiority of once daily deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis. Positive topline results from the first Phase 3 trial, POETYK PSO-1, were announced in November 2020. The company and key investigators will complete a full evaluation of the POETYK PSO-2 data and share the detailed results at a future medical meeting.

“Deucravacitinib was designed to be a selective TYK2 inhibitor that inhibits the IL-12, IL-23 and Type 1 IFN pathways, which are implicated in multiple immune-mediated diseases. The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb, in a news release. “The encouraging data we have seen to date suggest deucravacitinib may become an important oral treatment option for people living with psoriasis. We look forward to discussing the results from the POETYK PSO-1 and POETYK PSO-2 registrational studies with health authorities, with the goal of offering this novel therapy to those suffering from this serious disease as soon as possible.”