--Deucravacitinib demonstrated efficacy regardless of baseline characteristics, including body weight, disease severity and previous treatment with biologic or non-biologic therapies
--Patients on deucravacitinib demonstrated significantly greater improvements from baseline in psoriasis signs and symptoms compared with placebo and Otezla(R) (apremilast) at Week 16, with the greatest improvement in symptoms reported for itch and skin tightness
--No clinically meaningful changes from baseline levels in laboratory parameters compared to placebo or Otezla, consistent with data previously presented, with findings confirming no cumulative trends
Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 - October 2, 2021. The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company's data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, as well as the emerging dermatology pipeline.
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Clinical research being presented at the meeting includes findings from new analyses of the global pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 trials in moderate to severe plaque psoriasis showing deucravacitinib demonstrated:
Durable efficacy through one year of treatment, with maximum response rates achieved by Week 24 [as measured by Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100, static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) and sPGA 0] and maintained through Week 52 (POETYK PSO-1). These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 - 4:45 p.m. CEST. Deucravacitinib also demonstrated durable efficacy in scalp psoriasis through 52 weeks of treatment (Poster Number: P1391). Efficacy across a broad range of patient subgroups, with a consistently higher percentage of patients receiving deucravacitinib versus placebo and Otezla(R) (apremilast) achieving PASI 75 and sPGA 0/1 response at Week 16 regardless of prior psoriasis treatment, baseline disease characteristics and baseline demographic factors. Data on the efficacy of deucravacitinib, regardless of prior psoriasis treatment (Presentation FC03.06), were featured as an oral presentation today from 2:30 - 3:30 p.m. CEST. Significantly greater improvements from baseline of signs and symptoms of psoriasis compared with placebo and Otezla in all individual psoriasis symptom and sign scores at Week 16 as measured by the Psoriasis Symptoms and Signs Diary (PSSD). The greatest improvements in psoriasis symptoms were reported for itch and skin tightness, and the greatest improvements in psoriasis signs were reported for dryness, scaling and shedding or flaking (Poster Number: P1473).
As previously presented in the initial readout of the POETYK PSO-1 and POETYK PSO-2 results, deucravacitinib was well-tolerated and had a similar safety profile in both trials, with no new safety signals identified through 52 weeks of data. Laboratory data now shown from the trials for Weeks 0 to 52 (beyond what was initially presented for Weeks 0 to 16) confirmed no clinically meaningful changes from baseline levels observed in any laboratory parameters, including total cholesterol, creatine phosphokinase, neutrophils and platelets, which are four parameters that are known to change with Janus kinase (JAK) 1, 2 and 3 inhibition, and confirmed no cumulative trends (Poster Number: P1407).
"In clinical practice, dermatologists treat a wide range of people living with moderate to severe plaque psoriasis, many of whom remain undertreated or even untreated and are in need of safe and well-tolerated oral therapies that provide durable efficacy," said Professor Richard B. Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust and Professor at The University of Manchester. "These new data show that deucravacitinib is efficacious, regardless of prior treatment and across patient subgroups, and that the strong response rates achieved in the pivotal studies at Week 16 improved to Week 24 and were maintained from Week 24 through one year. The results provide further evidence that deucravacitinib has the potential to become an important new oral treatment for those who require systemic therapy."
Additional data from Bristol Myers Squibb's dermatology pipeline being presented at the meeting include translational research assessing a potential therapy target for alopecia areata, for which there is currently no approved therapy; preclinical research on a novel sphingosine 1-phosphate receptor (S1PR) 1, 4 and 5 modulator (S1PR1,4,5) found to be highly efficacious in a mouse model of atopic dermatitis; and health economics and outcomes research on a predictive model from real-world data for identifying patients with psoriasis who are at risk for developing psoriatic arthritis.
"This robust body of research presented at EADV's 30th Anniversary Congress shows Bristol Myers Squibb's commitment to transforming medicine through science in diseases like moderate to severe plaque psoriasis and demonstrates the progress we are making as we build a differentiated portfolio of new treatments for serious dermatologic immune-mediated conditions," said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. "By focusing on addressing the pressing treatment gaps that continue to exist for those impacted by dermatologic diseases, our goal is to elevate standards of care and deliver novel, well-tolerated therapies that help patients achieve better disease control."
Bristol Myers Squibb-sponsored abstracts presented at EADV's 30th Anniversary Congress can be found below and accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibb's scientific approach and resources on dermatologic immune-mediated diseases.
Late Breaking Presentation
Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials Author: Richard Warren Presentation Number: 2857 Thursday, September 30, 3:45 - 4:45 p.m. CEST Late Breaking News Session
Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Prior Treatment in the Phase 3 POETYK PSO-1 and PSO-2 Trials Author: Richard Warren Presentation Number: FC03.06 Thursday, September 30, 2:30 - 3:30 p.m. CEST Oral presentation Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active Psoriatic Arthritis in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Author: Philip Mease Poster Number: P0371 Presentation Topic: Biologics, Immunotherapy, Targeted Therapy Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Scalp Psoriasis: Analysis of the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials Author: Andrew Blauvelt Poster Number: P1391 Presentation Topic: Psoriasis Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy by Prespecified Baseline Demographics in the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials Author: Melinda Gooderham Poster Number: P1393 Presentation Topic: Psoriasis Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Integrated Laboratory Parameter Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials Author: Diamant Thaci Poster Number: P1407 Presentation Topic: Psoriasis Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Efficacy Analysis by Baseline Disease Characteristics from the Phase 3 POETYK PSO-1 and PSO-2 Trials Author: Joseph F. Merola Poster Number: P1410 Presentation Topic: Psoriasis Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Onset of Action in the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials Author: Neil Korman Poster Number: P1411 Presentation Topic: Psoriasis Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary Using Patient-Derived Outcomes from the Phase 3 POETYK PSO-1 and PSO-2 Trials of Deucravacitinib Versus Placebo and Apremilast in Moderate to Severe Plaque Psoriasis Author: Kim A. Papp Poster Number: P1453 Presentation Topic: Psoriasis Deucravacitinib Improves Psoriasis Symptoms and Signs Diary Domain Scores in Patients with Moderate to Severe Plaque Psoriasis: Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies Author: April Armstrong Poster Number: P1473 Presentation Topic: Psoriasis
BMS-986166, a Novel S1PR1,4,5 Modulator, is Highly Efficacious in a Mouse Model of Atopic Dermatitis Author: Jenny Xie Poster Number: P0176 Presentation Topic: Atopic Dermatitis/Eczema
Translational & Clinical Pharmacology Presentations
Selective Inhibition of Tyrosine Kinase 2 (TYK2) Protects Hair Follicles from Immune Privilege Collapse Induced by Interleukin (IL)-12 Stimulation Author: Janin Edelkamp Presentation Number: FC02.04 Thursday September 30, 2021, 11:15 a.m. - 12:15 p.m. CEST Oral Presentation Deucravacitinib, a Selective Tyrosine Kinase 2 (TYK2) Inhibitor: Overview of Clinical Pharmacology Including ADME, Food and pH Effects, Pharmacokinetics in Special Populations, and Drug-Drug Interactions Author: Anjaneya Chimalakonda Poster Number: P1336 Presentation Topic: Psoriasis
Health Economics and Outcomes Research (HEOR) Presentations
Treatment Patterns for Targeted Therapies and Non-targeted Therapies, and Drug Holiday in Patients with Psoriasis Author: April Armstrong Poster Number: P1371 Presentation Topic: Psoriasis Switch Rate Among Psoriasis Patients Initiating Apremilast or Biologics Author: Jashin J. Wu Poster Number: P1372 Presentation Topic: Psoriasis Predictive Model from Real-World Data for Identifying Patients with Psoriasis who are at Risk for Developing Psoriatic Arthritis Author: Joe Zhuo Poster Number: P1373 Presentation Topic: Psoriasis Patient Perspective of the Meaningful Change in Psoriasis Symptoms and Signs: A Qualitative Evidence Study Author: Farah Toublan Poster Number: P1374 Presentation Topic: Psoriasis Suboptimal Clinical and Quality of Life Outcomes in Psoriasis Patients Undertreated with Systemic Oral Therapies: Evidence from an International Physician and Patient Survey Author: Sydney Thai Poster Number: P1376 Presentation Topic: Psoriasis Development and Validation of a Claims-Based Algorithm to Identify Psoriasis Severity Author: Joe Zhuo Poster Number: P0692 Presentation Topic: Dermatology and Internal medicine, Including Skin Manifestations of Systemic Diseases
Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action and is the first and only selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-23, IL-12 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. 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 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(R) (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, were 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 response and those 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 and other measures evaluating deucravacitinib versus placebo and Otezla. Bristol Myers Squibb thanks the patients and investigators who participated in these clinical trials.
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, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Nearly one-quarter of people with psoriasis have cases that are considered moderate to severe. 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. Despite the availability of effective systemic therapy, many patients with moderate to severe psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients' well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.
Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients' Lives
Bristol Myers Squibb is inspired by a single vision - transforming patients' lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and multiple sclerosis. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission - and perhaps even cures - in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most - the promise of living a better life.
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(R) (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. 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, 2020, 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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SOURCE: Bristol Myers Squibb
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