Bristol Myers Squibb Drug Meets Main Goal in Phase 3 IPF Trial

what happened

Reuters and Dow Jones Newswires reported that Bristol Myers Squibb said its Phase 3 ALOFT-IPF trial of admilparant in adults with idiopathic pulmonary fibrosis met its primary endpoint. The 52-week study compared two twice-daily doses with placebo.

The 60-milligram dose produced a statistically significant improvement in the absolute change in forced vital capacity, or FVC, from baseline versus placebo. The 120-milligram dose slowed the decline in FVC, but the result was not statistically significant. The company also described admilparant’s safety and tolerability profile as favorable.

Bristol Myers Squibb said it would conduct a comprehensive assessment of the data and work with health authorities on planned regulatory submissions. Detailed findings are expected to be presented at a future medical meeting. Topline results from the separate Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis are expected in early 2027. The company’s shares rose 5.8% to $62.57 in Monday premarket trading. Separately, Bristol Myers Squibb reported positive interim-analysis results from a Phase 3 trial of RYZ101 in certain patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

why it matters

Idiopathic pulmonary fibrosis is a chronic, life-threatening disease in which lung tissue becomes irreversibly damaged and scarred. It affects about 1.4 million people globally, has a median survival of three to five years after diagnosis and a five-year survival rate of about 45%. The trial outcome could affect investors’ assessment of Bristol Myers Squibb’s new-treatment pipeline.

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