Bristol Myers Squibb’s admilparant met the primary endpoint in a phase 3 trial of adults with idiopathic pulmonary fibrosis (IPF) at the 60 mg twice-daily dose, while the 120 mg dose did not achieve statistical significance.
The 3 ALOFT-IPF trial evaluated the efficacy, safety and tolerability of admilparant, a potential first-in-class, orally administered, potent and selective lysophosphatidic acid receptor 1 (LPA1) antagonist at two dose levels twice daily for ≥52 weeks against placebo. 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.
Admilparant demonstrated a well-tolerated safety profile across both doses in the trial.
IPF is the most common type of progressive fibrosing interstitial lung disease. Pulmonary fibrosis is a fatal disease with a median survival time of three to five years following diagnosis and a five-year survival rate of approximately 45%.