Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) on Monday announced topline results from its Phase 3 ALOFT-IPF trial, which met its primary endpoint in evaluating admilparant in adults with idiopathic pulmonary fibrosis (IPF).
The 60 mg twice-daily dose demonstrated a statistically significant improvement in absolute change in forced vital capacity (FVC) from baseline at Week 52 compared with placebo, while the 120 mg twice-daily dose slowed FVC decline but did not achieve statistical significance.
Admilparant demonstrated a favourable safety and tolerability profile at both doses, with adverse event-related discontinuations low and similar to placebo. The company said the findings support the drug's potential as a first-in-class treatment for IPF.
Bristol Myers Squibb will complete a comprehensive analysis of the trial data and engage with health authorities to support planned regulatory submissions, with detailed findings scheduled for presentation at a future medical meeting.
The company is also evaluating admilparant in the fully enrolled Phase 3 ALOFT-PPF trial for progressive pulmonary fibrosis (PPF), with topline results expected in early 2027.
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