Instant Report

Date: 06-Nov-2020

Bristol Myers Announces Positive Results From POETYK PSO-1 Phase 3 Study Of Deucravacitinib To Treat Severe Psoriasis Patients

Bristol Myers Squibb 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 per cent 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.”

“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.”

Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1, Bristol Myers Squibb is evaluating deucravacitinib in four additional phase 3 studies: POETYK PSO-2 (NCT03611751); POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for any use in any country.

PrOgram to evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor PSO-1 (POETYK PSO-1, NCT03624127) is the first of two global phase 3 studies designed to evaluate safety and efficacy of deucravacitinib compared to placebo and Otezla (apremilast) in patients with moderate to severe plaque psoriasis. POETYK PSO-1 is a multi-center, randomized, double-blind, placebo- and active comparator-controlled phase 3 study. In total, 666 participants diagnosed with moderate to severe plaque psoriasis were randomized in the study.

The co-primary outcome measures of the trial were the percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75 and the percentage of participants who achieved static Physician's Global Assessment (sPGA) score of 0 to 1 at Week 16 versus placebo. Key secondary outcome measures of the trial include percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16.

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, impacting at least 100 million people worldwide. Up to 90% of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. People with psoriasis can experience social stigma that can lead to significant psychological distress, while accompanying pain can cause functional disability and reduced quality of life. Psoriasis is associated with multiple comorbidities that are known to reduce life expectancy, including cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, depression and malignancies