Phase 2 study shows 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 62% relative reduction in the rate of decline in percent predicted forced vital capacity (ppFVC) versus placebo

BMS-986278 was well tolerated with rates of adverse events and treatment discontinuation comparable to placebo

Data demonstrate potential of BMS-986278 in pulmonary fibrosis and support progression into Phase 3

Bristol Myers Squibb (NYSE: BMY) today announced results from a Phase 2 study evaluating BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA₁) antagonist, in patients with idiopathic pulmonary fibrosis. The study showed twice-daily administration of 60 mg of BMS-986278 over 26 weeks reduced the rate of decline in percent predicted forced vital capacity (ppFVC) by 62% compared to placebo. Pulmonary fibrosis is a devastating, life-threatening illness, with daily symptoms including coughing, labored breathing and extreme fatigue. These data were presented today at the American Thoracic Society 2023 International Conference held May 19-24, 2023, in Washington, D.C.

“As a treating physician, I am acutely aware of the urgent need for new pulmonary fibrosis treatment options that can improve symptoms, address the underlying cause of disease and are well tolerated by patients,” said Tamera J. Corte, clinical trial investigator and Consultant Respiratory Physician and Director of Interstitial Lung Disease, Department of Respiratory Medicine, Royal Prince Alfred Hospital. “These Phase 2 data for this potential first-in-class oral LPA₁ antagonist represent important progress for patients and physicians alike, who are eager for a new standard of care that can mitigate the decline of lung function.”

In this Phase 2 study, patients were randomized (1:1:1) to placebo, 30 mg or 60 mg BMS-986278 twice-daily for 26 weeks. Two-thirds of patients were on background antifibrotic therapy during the trial. Patients who met prespecified blood pressure reduction criteria were to receive a dose reduction to 10 mg of BMS-986278 or matching placebo twice-daily. Dose reductions due to blood pressure criteria were implemented in 5% (placebo), 8% (30 mg) and 6% (60 mg) of patients. The primary endpoint was rate of change in ppFVC from baseline through 26 weeks as assessed based on two prespecified estimands:

• The treatment policy estimand (similar to an Intention-to-Treat [ITT] analysis) included all observed data regardless of dose reduction and provides an estimate of efficacy with dose reduction as part of the treatment regimen.
• The while-on-treatment estimand included all observed data prior to dose reduction and provides an estimate of efficacy without dose reduction as part of the treatment regimen. A similar number of patients received dose reduction across the placebo (n=5), 30 mg (n=7) and 60 mg (n=6) treatment arms.

A prespecified Bayesian analysis was utilized to provide the probability of a positive treatment difference for BMS-986278 compared to placebo.

Treatment with 60 mg of BMS-986278 led to a 62% relative reduction in the rate of change in ppFVC versus placebo in the while-on-treatment analysis (1.8% mean difference in the rate of change in ppFVC versus placebo [95% CI; 0.2, 3.4]), and a 54% reduction versus placebo in the treatment policy analysis (1.4% mean difference in the rate of change in ppFVC versus placebo [95% CI; −0.1, 3.0]). The Bayesian analysis showed a greater than 95% probability that 60 mg of BMS-986278 was superior compared to placebo in reducing the rate of decline in ppFVC over 26 weeks in both the while-on-treatment and treatment policy estimands. The 30 mg dose was not effective compared to placebo.

BMS-986278 was well tolerated in both treatment arms with rates of adverse events, including rates of gastrointestinal side effects, and treatment discontinuation comparable to placebo. In the placebo, 30 mg and 60 mg arms, adverse events (AEs) occurred in 80%, 76% and 74% of patients, respectively, while serious AEs occurred in 17%, 11% and 11% of patients, respectively. The most frequent AEs in the placebo, 30 mg and 60 mg arms included diarrhea (12%, 11%, 11%), cough (5%, 8%, 11%) and orthostatic hypotension (10%, 8%, 5%). Treatment discontinuation rates due to AEs were comparable to placebo, occurring in 10%, 10% and 7% of patients in the placebo, 30 mg and 60 mg arms, respectively.

“The in-house development of BMS-986278 and progress of our pulmonary fibrosis program are a direct result of our industry-leading drug discovery and development capabilities, underscoring our expertise in disease biology and medicinal chemistry,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb. “These Phase 2 data give us the confidence to initiate our global Phase 3 clinical trial program where we will continue exploring BMS-986278 as a potentially new and meaningful therapeutic option for people with pulmonary fibrosis.”

Bristol Myers Squibb would like to thank the patients and investigators who were involved in this study.

About BMS-986278

BMS-986278 is a potential first-in-class, oral, small molecule lysophosphatidic acid receptor 1 (LPA₁) antagonist currently being evaluated as a novel antifibrotic treatment for patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Increased LPA levels and activation of LPA₁ have been implicated in the pathogenesis of pulmonary fibrosis. A preclinical in vitro and in vivo study found that antagonizing LPA₁ may be beneficial in treating lung injury and fibrosis.

About the BMS-986278 Phase 2 Trial

This Phase 2 trial was a global, randomized study in which patients with idiopathic pulmonary fibrosis received 30 mg or 60 mg of BMS-986278 or matched placebo orally twice-daily. Overall, 278 patients were randomized and 276 received treatment. The study consisted of a 26-week placebo-controlled treatment period, an optional 26-week active treatment extension period and a 4-week post-treatment follow-up period. Patients were permitted to take background antifibrotic treatment. The primary endpoint was rate of change in percent predicted forced vital capacity (ppFVC) from baseline to week 26. ppFVC compares the observed FVC to that which is expected for a healthy person of the same age, gender, race and height. Patients who met prespecified blood pressure reduction criteria were to receive a dose reduction to 10 mg of BMS-986278 or matching placebo twice-daily. A separate cohort of patients with progressive pulmonary fibrosis is ongoing.

More information can be found on www.clinicaltrials.gov (NCT04308681).

About Pulmonary Fibrosis

Pulmonary fibrosis is a chronic, life-threatening interstitial lung disease (ILD) that occurs when lung tissue becomes damaged and scarred, impacting how lungs function. Progressive pulmonary fibrosis is the preferred term to describe patients who have an ILD with a progressive fibrotic phenotype. Idiopathic pulmonary fibrosis is the most common type of progressive fibrosing ILD. As an idiopathic disease, there is no identifiable cause, and as of 2021, more than 700,000 adults are living with IPF globally.

Many people living with PPF and IPF are physically impaired, experience a progressive decline in lung function, have difficulty performing simple daily activities due to breathlessness and require continuous supplemental oxygen to ease the burden of normal breathing.

IPF is a fatal disease with a median survival time of 3-5 years following diagnosis and 5-year survival rate of approximately 45%. Innovation in treatment has been limited with few new therapies approved in nearly 10 years.

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 pulmonology. 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.

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 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 may not be consistent with the results to date, that the product candidate may not achieve its primary study endpoints or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, 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, 2022, 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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At #ATS2023, $BMY presented new data on lung function decline for an investigational medicine for patients with idiopathic #pulmonaryfibrosis.