Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)

Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)

Superiority of deucravacitinib was demonstrated on both co-primary endpoints and multiple key secondary endpoints in the POETYK PSO-2 trial

The overall safety profile remains consistent with previously reported results and consistent with the mechanism of action of deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today 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. 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.

Dr. Bruce Strober, M.D., Ph.D., 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. “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.”

Bristol Myers Squibb thanks the patients and investigators who participated in the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials.

About Deucravacitinib

Deucravacitinib is the first and only novel, once daily, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to be a selective TYK2 inhibitor, inhibiting interleukin (IL)-12, IL-23 and Type 1 interferon (IFN) pathways, which are implicated in the pathogenesis of psoriasis and other immune-mediated diseases. Deucravacitinib achieves selectivity by binding to the regulatory domain of TYK2, which is structurally distinct from the Janus kinase (JAK) 1, 2 and 3 kinases. Deucravacitinib does not inhibit JAK 1, 2, 3 at clinically relevant concentrations. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

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

About the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies

PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla^® (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, are multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 and the percentage of patients who achieved static Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints of the trials included the 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 percent 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.