Bristol Myers Squibb reports Phase 3 ALOFT-IPF results: admilparant 60 mg met the primary endpoint, while 120 mg did not achieve statistical significance.
Written by: Saniya Katakdhond, PharmD
Reviewed by: Pharmacally Editorial Team
Bristol Myers Squibb (BMS) announced topline results from the Phase 3 ALOFT-IPF trial (NCT06003426), evaluating admilparant (BMS-986278), an investigational oral lysophosphatidic acid receptor 1 (LPA1) antagonist, in adults with idiopathic pulmonary fibrosis (IPF). The 60 mg twice-daily dose met the primary endpoint of change in forced vital capacity (FVC) at Week 52, whereas the 120 mg dose did not achieve statistical significance compared with placebo.
BMS also reported a favorable safety and tolerability profile across both dose groups. The findings represent a pivotal development milestone for admilparant, although numerical efficacy estimates and detailed safety results will be needed to establish the magnitude of benefit and characterize its overall benefit-risk profile.
The 60 mg Dose Meets the Primary Endpoint
ALOFT-IPF was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that enrolled approximately 1,255 adults aged 40 years or older with IPF. Participants were assigned in a 1:1:1 ratio to admilparant 60 mg twice daily, admilparant 120 mg twice daily or placebo.
The primary endpoint was absolute change in FVC from baseline to Week 52. FVC measures the volume of air a person can forcibly exhale after taking a deep breath and is an established measure of lung function in IPF.
The 60 mg dose demonstrated a statistically significant benefit compared with placebo. Although the 120 mg dose slowed lung-function decline, it did not achieve statistical significance.
This difference in statistical outcomes is a central finding of the announcement. However, statistical significance at one dose and its absence at another do not, by themselves, establish that the lower dose is more effective or explain why the results differed. Comparative treatment-effect estimates and additional analyses will be needed to clarify the findings.
The topline announcement does not provide numerical treatment effects, confidence intervals or p-values. These data will be important for evaluating the magnitude and precision of the observed benefit and its potential clinical relevance.
LPA1 Inhibition Targets Pathways Involved in Pulmonary Fibrosis
Admilparant is an investigational, orally administered, selective LPA1 antagonist being developed for IPF and progressive pulmonary fibrosis (PPF). LPA1 signaling is implicated in biological processes associated with fibrosis, including inflammation, vascular leakage and fibroblast activation and expansion.
By targeting this pathway, BMS is investigating an approach intended to address mechanisms involved in fibrotic lung disease. However, the reported primary endpoint measures lung function. The topline findings do not establish that admilparant reverses existing lung scarring or improves survival, symptoms or quality of life.
Earlier Phase 2 findings provide additional context. According to BMS, admilparant 60 mg twice daily over 26 weeks was associated with relative reductions in the rate of lung-function decline versus placebo of 62% in participants with IPF and 69% in those with PPF.
These findings came from a separate Phase 2 study and should not be interpreted as the treatment effect observed in ALOFT-IPF. The Phase 3 result adds pivotal-study evidence to the development program, but the absence of numerical efficacy estimates limits assessment of the benefit demonstrated in the current trial.
Safety Findings Support Further Evaluation
BMS reported a favorable safety and tolerability profile across both admilparant dose groups. Discontinuations due to adverse events were low and similar to those observed with placebo.
Tolerability is an important consideration for a potential long-term treatment for IPF. Nevertheless, discontinuation rates alone do not establish the overall safety profile. Detailed adverse-event frequencies, serious adverse events, laboratory findings and other safety measures will be needed to assess the treatment’s benefit-risk profile.
The topline announcement does not provide a comprehensive numerical breakdown of safety findings. Accordingly, the available information supports further evaluation but does not permit a detailed comparison of safety between the two doses.
ALOFT-PPF Results Expected in Early 2027
BMS plans to complete a comprehensive evaluation of the ALOFT-IPF data and engage with health authorities to support planned regulatory submissions. Detailed results are expected to be presented at a future medical meeting.
Admilparant is also being evaluated in the fully enrolled Phase 3 ALOFT-PPF trial (NCT06025578), which enrolled approximately 1,057 adults with progressive pulmonary fibrosis. Topline results are anticipated in early 2027.
The ALOFT-PPF findings may determine whether the investigational treatment’s potential extends to other forms of progressive fibrosing lung disease. For ALOFT-IPF, the immediate priorities are the full efficacy and safety dataset, clarification of the dose-specific findings, and subsequent regulatory assessment.
Sources
Bristol Myers Squibb. Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint. October 12, 2026.
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis, NCT06003426.
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis, NCT06025578.
About the Writer
Saniya Sanjay Katakdhond (Linkedin) is a Doctor of Pharmacy professional with hands-on experience in patient case review, clinical documentation, medical record analysis, and patient care.
Her hospital experience has strengthened her understanding of clinical conditions, treatment approaches, and multidisciplinary healthcare practices.
With ICH-GCP certification and a research-oriented approach, she brings clinical insight and attention to detail to healthcare content development.
As a healthcare writer, Saniya focuses on translating clinical knowledge and patient-care experience into clear, accurate, and evidence-informed medical content.