Full Breakdown
Bristol Myers’ Admilparant Shows Dose-Dependent Efficacy in Late-Stage IPF Trial
By Drooid · · How we work
Core Event: Phase 3 ALOFT-IPF Results
Bristol Myers Squibb announced that the 60 mg twice-daily dose of its experimental LPA1 antagonist admilparant met the primary endpoint of the Phase 3 ALOFT-IPF trial, showing a statistically significant reduction in forced vital capacity (FVC) decline over 52 weeks compared with placebo. The higher 120 mg dose slowed decline numerically but did not achieve statistical significance. Both dose groups were described as well tolerated, with adverse-event discontinuations comparable to placebo. The trial enrolled approximately 1,255 adults with idiopathic pulmonary fibrosis (IPF) and was double-blind, placebo-controlled.
Background & Context
IPF is a progressive lung-scarring disease affecting an estimated 1.4 million people worldwide. Current therapies—nintedanib, pirfenidone, and the newer PDE4B inhibitor Jascayd—target different pathways and have limitations. Admilparant blocks the lysophosphatidic acid-1 (LPA1) receptor, a signaling node implicated in fibroblast activation and tissue scarring. Earlier LPA1 programs were discontinued after liver-toxicity signals (Bristol Myers) or failed Phase 2 results (Amgen). Continuum Therapeutics is pursuing a separate LPA1 antagonist, PIPE-791, in a Phase 2 trial.
Data & Statistics
- Patients: ~1,255 randomized participants.
- Doses: 60 mg BID and 120 mg BID versus placebo.
- Primary endpoint: Absolute change in FVC from baseline to week 52.
- Outcome: 60 mg dose achieved statistical significance; 120 mg dose did not.
- Safety: Low discontinuation rates, similar across all arms; detailed safety metrics not disclosed.
- Market reaction: Shares rose >6 % in pre-market trading before settling at a roughly 4 % loss; Contineum Therapeutics stock fell about 30 % following the readout.
Official Statements & Responses
The company added that it will engage with health authorities and present detailed results at a future medical meeting. “The company will complete a comprehensive evaluation of the Phase 3 ALOFT-IPF trial data and engage with health authorities to support planned regulatory submissions, with detailed results to be presented at a future medical meeting,” — Bristol Myers
Conflicting Reports & Gaps
The company’s topline release omitted the magnitude of FVC preservation, confidence intervals, and p-values for both dose groups, preventing assessment of the clinical relevance of the 60 mg benefit. Detailed safety tables were also not provided, leaving the safety profile incompletely characterized.
Verbatim Quotes
- “The company will complete a comprehensive evaluation of the Phase 3 ALOFT-IPF trial data and engage with health authorities to support planned regulatory submissions, with detailed results to be presented at a future medical meeting,” — Bristol Myers
What’s Next
Bristol Myers plans regulatory discussions with health authorities and aims to present full trial data at an upcoming medical conference. A companion study evaluating admilparant in non-idiopathic progressive pulmonary fibrosis (ALOFT-PPF) is slated for readout in early 2027. The company also reported positive late-stage results for its radiopharmaceutical RYZ-101 in neuroendocrine tumors.
