PRINCETON, N.J. — October 11, 2026
Bristol Myers Squibb (NYSE: BMY) announced positive topline results from its pivotal Phase 3 ALOFT-IPF trial evaluating admilparant (BMS-986278) in adults with idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by irreversible scarring. The study met its primary endpoint at the 60 mg twice-daily dose, demonstrating a statistically significant benefit versus placebo in absolute change in forced vital capacity (FVC) from baseline to Week 52. The 120 mg dose slowed FVC decline but did not achieve statistical significance. Admilparant also demonstrated a favorable safety and tolerability profile across both dose groups, with adverse-event-related treatment discontinuations reported as low and similar to placebo. The company plans a comprehensive analysis of the data and engagement with health authorities to support potential regulatory submissions.
Phase 3 ALOFT-IPF Trial Meets Primary Endpoint
The randomized, double-blind, placebo-controlled ALOFT-IPF Phase 3 trial evaluated two doses of admilparant, 60 mg and 120 mg administered twice daily, against placebo for at least 52 weeks. Approximately 1,255 adults aged 40 years and older with IPF were enrolled and assigned to the three treatment groups in a 1:1:1 ratio. The primary endpoint measured absolute change in FVC from baseline to Week 52, providing an assessment of changes in lung function over the treatment period. According to Bristol Myers Squibb, the 60 mg dose achieved a statistically significant improvement compared with placebo, meeting the study’s primary endpoint. The 120 mg dose slowed the decline in FVC, but the difference did not reach statistical significance. The company has not yet disclosed the detailed numerical treatment effects or p-values in its topline announcement. Full data are expected to be presented at a future medical meeting, where clinicians and researchers will be able to evaluate the magnitude and clinical relevance of the findings in greater detail.
Admilparant Targets the LPA1 Pathway in Pulmonary Fibrosis
Admilparant is an investigational oral lysophosphatidic acid receptor 1 (LPA1) antagonist designed to target biological processes involved in pulmonary fibrosis. Increased lysophosphatidic acid levels and activation of the LPA1 pathway are associated with the development and progression of fibrotic lung disease. Bristol Myers Squibb is investigating whether inhibiting this pathway can help reduce fibrogenic activity and preserve lung function. The company describes admilparant as a potential first-in-class antifibrotic treatment for patients with IPF and progressive pulmonary fibrosis (PPF). Earlier Phase 2 findings supported continued development: treatment with 60 mg twice daily for 26 weeks was associated with a reported 62% relative reduction in the rate of lung function decline versus placebo among patients with IPF and a 69% relative reduction among patients with PPF. These earlier findings provide background for the Phase 3 program but should be interpreted separately from the current trial results. The Phase 3 findings remain topline results, and the complete dataset will be important for assessing the treatment’s efficacy, safety and potential role in clinical practice.
Favorable Safety Profile and Next Development Milestones
Bristol Myers Squibb reported that admilparant demonstrated a favorable safety and tolerability profile at both doses in ALOFT-IPF. Discontinuations due to adverse events were low and similar to those observed in the placebo group. Detailed safety data have not yet been provided in the topline announcement, so a fuller assessment will depend on the complete trial results. The company plans to conduct a comprehensive evaluation of the findings and engage with health authorities regarding planned regulatory submissions. Admilparant is also being evaluated in ALOFT-PPF, a separate Phase 3 trial investigating progressive pulmonary fibrosis across non-idiopathic forms of interstitial lung disease. That study is fully enrolled, with topline results anticipated in early 2027. Together, the two trials are intended to assess the potential of LPA1 inhibition across different forms of pulmonary fibrosis. IPF is a serious, progressive disease associated with declining lung function and substantial effects on daily activities. Although existing treatments can slow disease progression, additional treatment options remain needed. The ALOFT-IPF results represent a development milestone for admilparant, while the detailed data and future regulatory review will determine its eventual clinical significance.
Source::Bristol Myers Squibb,, press release



