The primary endpoint was absolute change in FVC (mL) from baseline to week 52.1 According to BMS, the 60 mg dose met this endpoint with a statistically significant improvement vs placebo, while the 120 mg dose slowed FVC decline without reaching statistical significance.1 No secondary endpoint results were reported.
BMS did not disclose the magnitude of FVC change in any arm, between-group differences, or how the statistical analysis plan handled the 2 dose comparisons. The failure of the higher dose to separate from placebo leaves the dose-response relationship unresolved until full data are available.
Admilparant safety and phase 2 data in pulmonary fibrosis
BMS reported admilparant was well tolerated at both doses, with discontinuations due to adverse events (AEs) low and similar to placebo in both admilparant arms.1 The release did not report AE rates, serious AEs, or deaths.
Key Takeaways
What is admilparant?
Admilparant (BMS-986278) is an investigational oral LPA1 antagonist in development by BMS for IPF and PPF. It is not approved by the US Food and Drug Administration.
How does admilparant work?
Admilparant selectively blocks LPA1, a receptor BMS links to faulty epithelial repair, vascular leakage, and fibroblast activation and expansion in pulmonary fibrosis.
What did the ALOFT-IPF trial show?
In approximately 1,255 adults with IPF, admilparant 60 mg twice daily significantly improved absolute FVC change at week 52 vs placebo, while 120 mg did not reach statistical significance, according to topline results.
In the 26-week phase 2 trial published in the American Journal of Respiratory and Critical Care Medicine, 278 patients with IPF and 125 with progressive pulmonary fibrosis (PPF) were randomized 1:1:1 to admilparant 30 mg, admilparant 60 mg, or placebo twice daily.2 In the IPF cohort, the rate of change in percent predicted FVC (ppFVC) was −1.2% with 60 mg vs −2.7% with placebo (difference, 1.4%; 95% CI, −0.1 to 3.0).2 BMS has characterized this result as a 62% relative reduction in lung function decline.1
In the phase 2 IPF cohort, discontinuations due to treatment-emergent AEs occurred in 6.5% of the 60 mg group vs 9.8% of the placebo group.2 Diarrhea was the most common AE, and transient day 1 postdose blood pressure reductions were greater with admilparant than placebo.2
"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 interim chair of the department of medicine, UMass Chan Medical School.
BMS plans to complete a full evaluation of the ALOFT-IPF data and engage health authorities ahead of planned regulatory submissions, with detailed results to be presented at a future medical meeting.1 The phase 3 ALOFT-PPF trial (NCT06025578), which enrolled approximately 1,057 adults with PPF with or without stable background antifibrotic therapy, is fully enrolled, with topline results expected in early 2027.1
References
Bristol Myers Squibb. Bristol Myers Squibb announces phase 3 ALOFT-IPF trial evaluating admilparant in adults with idiopathic pulmonary fibrosis met primary endpoint. Published October 12, 2026. Accessed October 12, 2026. https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Phase-3-ALOFT-IPF-Trial-Evaluating-Admilparant-in-Adults-with-Idiopathic-Pulmonary-Fibrosis-Met-Primary-Endpoint/default.aspx
Corte TJ, Behr J, Cottin V, et al. Efficacy and safety of admilparant, an LPA1 antagonist, in pulmonary fibrosis: a phase 2 randomized clinical trial. Am J Respir Crit Care Med. 2025;211(2):230-238. doi:10.1164/rccm.202405-0977OC
