Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint
In the trial, admilparant at the 60 mg dose demonstrated a statistically significant benefit in absolute change in forced vital capacity (FVC) from baseline to Week 52 compared with placebo
Admilparant demonstrated a favorable safety and tolerability profile
The totality of the findings supports the potential of admilparant as a clinically meaningful first-in-class treatment
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced topline results from the pivotal Phase 3 ALOFT-IPF trial evaluating the efficacy, safety and tolerability of admilparant, a potential first-in-class, orally administered, potent and selective lysophosphatidic acid receptor 1 (LPA1) antagonist, in adults with idiopathic pulmonary fibrosis (IPF). The trial evaluated two dose levels of admilparant, 60 mg and 120 mg, twice daily for ≥52 weeks against placebo (1:1:1).
The trial met its primary endpoint at the 60 mg dose, with admilparant demonstrating a statistically significant improvement compared to placebo in absolute change in forced vital capacity (FVC) from baseline at Week 52. At the 120 mg dose, admilparant slowed the decline of FVC but was not statistically significant.
Notably, admilparant demonstrated a well-tolerated safety profile across both doses in the ALOFT-IPF trial. In both admilparant arms of the trial, discontinuations due to adverse events were low and similar to placebo.
“Taken together, these topline data reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF – one that reflects the innovation of targeting the LPA1 pathway as a first-in-class approach,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “We also look forward to sharing the topline results from the ALOFT-PPF trial early next year, as we continue working to improve outcomes for patients with pulmonary fibrosis.”
“IPF remains one of the most complex and challenging lung diseases to treat, with unpredictable progression, irreversible scarring and a profound impact on patients’ daily lives,” said Fernando Martinez, MD, chair of the ALOFT program clinical steering committee and the Joseph D. Early Chair in Biomedical Research, interim chair and professor of medicine at UMass Chan Medical School. “These admilparant results represent an important advancement as there remains a need for therapies that are both effective and tolerable for patients living with IPF.”
The company willcomplete a comprehensive evaluation of the Phase 3 ALOFT-IPF trial data and engage with health authorities to support planned regulatory submissions, with detailed results to be presented at a future medical meeting.
Admilparant is also being studied in the fully enrolled Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis (PPF), with topline results anticipated in early 2027.
Bristol Myers Squibb thanks the patients and investigators who participated in the ALOFT-IPF clinical trial.
About Pulmonary Fibrosis
Pulmonary fibrosis is a chronic, life-threatening interstitial lung disease (ILD) that occurs when lung tissue becomes irreversibly damaged and scarred, impacting how the lungs function. Idiopathic pulmonary fibrosis (IPF) is the most common type of progressive fibrosing ILD. As an idiopathic disease, there is no identifiable cause, and approximately 1.4 million people live with IPF globally. Progressive pulmonary fibrosis (PPF) describes patients with non-idiopathic forms of ILD. These include connective tissue disease-related lung diseases, such as rheumatoid arthritis-associated ILD and scleroderma-associated ILD, and other types, such as environmental lung fibrosis, which is caused by exposure to dust or chemicals.
Many people with pulmonary fibrosis are physically impaired, experience a progressive decline in lung function, have difficulty performing simple daily activities due to breathlessness and chronic cough and require continuous supplemental oxygen to ease the burden of normal breathing.
Pulmonary fibrosis is a fatal disease with a median survival time of three to five years following diagnosis and a five-year survival rate of approximately 45%. Innovation in treatment has been limited, with very few new therapies approved in more than 10 years. Currently approved treatments can slow the decline of lung function; however, there remains a need for additional safe and tolerable therapies which allow patients to manage their disease while they continue to perform daily activities.
About the Phase 3 ALOFT Trial Program
ALOFT-IPF (IM027-068; NCT06003426) and ALOFT-PPF (IM027-1015; NCT06025578) are Phase 3, multicenter, randomized, double-blind, placebo-controlled trials. ALOFT-IPF enrolled approximately 1,255 adults (≥40 years) with idiopathic pulmonary fibrosis (IPF), while ALOFT-PPF enrolled approximately 1,057 adults (≥21 years) with progressive pulmonary fibrosis (PPF), with or without stable background antifibrotic therapy. The trials include both a 60 mg and 120 mg dose arm (twice daily for ≥52 weeks) against placebo (1:1:1), assessing the efficacy, safety and tolerability of admilparant.
The primary endpoint for the registrational portions of the trials is absolute change in forced vital capacity (FVC) from baseline to Week 52.
About Admilparant (BMS-986278)
Admilparant is a potential first-in-class, orally administered, potent, selective lysophosphatidic acid receptor 1 (LPA1) antagonist currently being evaluated as a novel antifibrogenic treatment for patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Increased LPA levels and activation of LPA1 are involved in the pathogenesis of pulmonary fibrosis.
In a global Phase 2 trial with parallel IPF and PPF cohorts, 26 weeks of treatment with admilparant 60 mg twice daily resulted in a 62% relative reduction in the rate of lung function decline versus placebo in patients with IPF and a 69% relative reduction in patients with PPF. Treatment effect was consistent with or without background therapy and admilparant was well tolerated in both cohorts, with rates of adverse events and treatment discontinuation comparable to placebo.
Bristol Myers Squibb’s research approach to IPF begins not at the point where fibrosis is visible, but at its origin, where epithelial cell injury and dysfunctional repair first emerge. Admilparant targets three key drivers of fibrogenesis: faulty epithelial cell repair, inflammation/vascular leakage and fibroblast activation and expansion.
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. Combining our patient-centric approach and deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Through our sequential immunotherapy research framework, which aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures.
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, 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 and may be unfavorable, that admilparant may not receive regulatory approval for the indications described in this release, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether admilparant for the indications 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, 2025, 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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