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Superiority of deucravacitinib was demonstrated on both co-primary endpoints and multiple key secondary endpoints in the POETYK PSO-1 trial
The overall safety profile of deucravacitinib in this study was consistent with previously reported Phase 2 results
POETYK PSO-1 is the first Phase 3 trial evaluating the efficacy and safety of deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases
Bristol Myers Squibb (NYSE:BMY) 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."
About Deucravacitinib
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.
About POETYK PSO-1
P r O gram to E valuate the efficacy and safety of BMS-986165, a selective TYK 2 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.
About Psoriasis
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.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
Otezla ® (apremilast) is a registered trademark of Amgen Inc.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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