Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

Rhea-AI Summary

Bristol Myers Squibb (NYSE: BMY) announced that the Phase 2 LATTICE-UC study for deucravacitinib, a selective TYK2 inhibitor for moderate to severe ulcerative colitis, failed to meet its primary endpoint of clinical remission at Week 12, as well as secondary endpoints. Despite this, the drug's safety profile remained consistent with earlier studies, showing no new safety signals. The company plans further evaluation in a second Phase 2 trial with higher doses. Notably, they maintain a revenue target of over $4 billion for deucravacitinib by 2029.

Positive

• Safety profile of deucravacitinib consistent with past trials, showing no new safety signals.
• Company continues to expect >$4 billion revenue by 2029 for deucravacitinib.

Negative

• LATTICE-UC study did not meet primary efficacy endpoint of clinical remission at Week 12.
• Secondary efficacy endpoints were also not met.

LATTICE-UC proof of concept study did not meet primary nor secondary endpoints

Safety profile of deucravacitinib consistent with other trials and no new safety signals reported

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 LATTICE-UC study evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at Week 12, nor secondary efficacy endpoints. The safety profile of deucravacitinib was consistent with previously reported studies in psoriasis and psoriatic arthritis, and no new safety signals were observed.

“Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.”

The company will complete a full review of the data from LATTICE-UC and the potential of deucravacitinib in UC continues to be evaluated in IM011-127, a second Phase 2 trial that also includes a higher dose.

Bristol Myers Squibb continues to expect greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.

About LATTICE-UC

LATTICE-UC (IM011-024) is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of deucravacitinib in participants with moderate to severe ulcerative colitis (UC). The primary endpoint of the trial is clinical remission (using the modified Mayo score) at Week 12. Secondary endpoints include clinical response (using the modified Mayo score), endoscopic response, and histological improvement at Week 12. More information can be found on www.clinicaltrials.gov (NCT03934216).

About IM011-127

IM011-127 is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety, efficacy and biomarker response of deucravacitinib in participants with moderate to severe ulcerative colitis (UC). The primary endpoints of the trial are clinical response and safety and tolerability at Week 12. More information can be found on www.clinicaltrials.gov (NCT04613518).

About Deucravacitinib

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. Deucravacitinib is not approved for use in any country.

About Ulcerative Colitis

Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), is characterized by an irregular, chronic immune response that creates inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that approximately 14.9 million people worldwide are living with IBD.

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.

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, the possibility of unfavorable results from further clinical trials involving the product candidate. 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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Bristol Myers Squibb

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Source: Bristol Myers Squibb

FAQ

What were the results of the LATTICE-UC study for BMY?

The LATTICE-UC study did not meet its primary or secondary endpoints, failing to show clinical remission at Week 12.

What is the future of deucravacitinib after the LATTICE-UC results?

Bristol Myers Squibb will further evaluate deucravacitinib in a second Phase 2 trial (IM011-127) with a higher dose.

What is the expected revenue for deucravacitinib by 2029 for BMY?

Bristol Myers Squibb expects over $4 billion in non-risk adjusted revenue for deucravacitinib by 2029.

How does the safety profile of deucravacitinib compare to previous trials?

The safety profile of deucravacitinib was consistent with earlier studies in psoriasis and showed no new safety signals.