Regulatory2026-10-12

Admilparant - (ALOFT-IPF)

Bristol-Myers Squibb CompanyBMY
Indication
Idiopathic Pulmonary Fibrosis
Stage
phase3
Event
Submission
Details

October 11, 2026: Bristol Myers Squibb (NYSE: BMY) reported topline results from the pivotal Phase 3 ALOFT-IPF trial of admilparant (BMS-986278), an oral LPA1 antagonist, in adults with idiopathic pulmonary fibrosis. The study tested 60 mg and 120 mg twice daily for at least 52 weeks versus placebo.

ALOFT-IPF met its primary endpoint at the 60 mg dose: admilparant showed a statistically significant improvement versus placebo in absolute change in forced vital capacity from baseline to Week 52. The 120 mg dose slowed FVC decline but was not statistically significant. Safety and tolerability were favorable across both doses, with adverse-event discontinuation rates low and similar to placebo.

The company said it will complete a full analysis of the Phase 3 data and engage with health authorities to support planned regulatory submissions. Detailed results are planned for a future medical meeting.

Admilparant is also being studied in the fully enrolled Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis, with topline results anticipated in early 2027. The release also cites prior Phase 2 data showing 26 weeks of 60 mg twice daily reduced the rate of lung function decline versus placebo by 62% in IPF and 69% in PPF.