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

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.

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.