Bristol Myers Squibb psoriasis med meets late-stage goal

Feb. 2, 2021

Bristol Myers Squibb announced 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.

Its experimental oral drug for plaque psoriasis significantly reduced the extent and severity of the skin condition and was more effective than a placebo and Amgen Inc’s Otezla says BMS.

POETYK PSO-2 evaluated deucravacitinib 6 mg 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 6 mg once daily was superior to Otezla (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.

"I am excited to see that the results from this second pivotal trial further support the promising efficacy and safety profile of deucravacitinib," said Dr. Bruce Strober, M.D., Ph.D., clinical professor of dermatology at Yale University School of Medicine and Central Connecticut Dermatology. "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.

Read the BMS statement.