NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb (BMY), a biopharmaceutical company, announced Monday the topline results from its pivotal Phase 3 ALOFT-IPF trial evaluating admilparant in adults with idiopathic pulmonary fibrosis (IPF).
Admilparant is a potential first-in-class, orally administered lysophosphatidic acid receptor 1 (LPA1) antagonist. The trial evaluated two dose levels of admilparant-60 mg and 120 mg-administered twice daily for at least 52 weeks against placebo in a 1:1:1 randomization.
The trial met its primary endpoint at the 60 mg dose. Admilparant demonstrated 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 did not achieve statistical significance.
Admilparant demonstrated a well-tolerated safety profile across both doses in the ALOFT-IPF trial. Discontinuations due to adverse events were low and similar to placebo in both admilparant arms.
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.
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