Bristol Myers' admilparant shows dose-dependent efficacy in IPF trial

Bristol Myers Squibb reported Phase 3 ALOFT-IPF trial results for admilparant on Oct. 12, 2026. The 60 mg twice-daily dose of the LPA1 receptor antagonist significantly slowed the decline in forced vital capacity over 52 weeks in adults with idiopathic pulmonary fibrosis compared to placebo.

Patients receiving the lower dose showed a statistically significant improvement in the absolute change in this key measure of breathing capacity. The trial evaluated admilparant as a potential new therapy for IPF, a progressive and fatal lung disease with limited treatment options.

Higher dose fails to meet significance

The higher 120 mg twice-daily dose of admilparant slowed the decline in lung function but did not reach statistical significance on the primary endpoint. The primary endpoint was met by the lower dose only. This outcome presents a mixed result, with the higher dose showing an impact on disease progression without achieving the trial's statistical benchmark.

Safety and tolerability profile

Both doses of admilparant were generally well tolerated. Bristol Myers Squibb stated that the drug demonstrated a well-tolerated safety profile. Treatment-related study discontinuations were low and similar between the admilparant groups and the placebo group.

Expert and analyst reactions

Experts noted the results as an advancement but raised concerns about the lack of a clear dose response. RBC Capital Markets analyst Trung Huynh described the finding as confounding. "The failure of the high-dose arm is 'confounding and requires further explanation'," Huynh said.

Fernando Martinez, trial steering committee chair and a medical professor at the University of Massachusetts, commented in a company statement. Leerink Partners analyst David Risinger noted the results could support regulatory approval but questioned the drug's profile. William Blair analyst Matt Phipps said the lower dose success is likely to open a blockbuster opportunity.

Next steps and broader context

Bristol Myers Squibb intends to complete a full review of the trial data and engage health authorities about next steps toward possible regulatory filings. Detailed results are planned for presentation at a future medical meeting. A related late-stage study of admilparant in a broader form of progressive lung fibrosis is expected to report results in early 2027.

The development path for LPA1 receptor antagonists has been challenging. Previous candidates from Bristol Myers were discontinued due to liver toxicity, and an Amgen candidate failed Phase 2 endpoints. Bristol Myers also previously revised trial protocols for admilparant in Europe, which had raised safety concerns. The company announced positive results from a separate late-stage trial in a rare cancer alongside the admilparant data. Bristol Myers Squibb intends to complete a full review of the admilparant trial data and engage health authorities about next steps toward possible regulatory filings.