Bristol Myers Squarb’s lung‑fibrosis drug admilparant meets primary endpoint in Phase 3 IPF trial
Bristol Myers Squibb reported topline data from the Phase 3 ALOFT‑IPF trial of its LPA1 antagonist admilparant. The 60 mg dose achieved a statistically significant improvement in forced vital capacity versus placebo after 52 weeks, while the 120 mg dose did not reach significance. The trial enrolled roughly 1,255 patients and showed a safety profile comparable to placebo. The company said it will engage health authorities for regulatory submissions and present detailed results at a future medical meeting.
Why it matters
The company’s plan to file for regulatory approval could add a new therapy for idiopathic pulmonary fibrosis, a disease with limited treatment options. Mixed market reaction reflects investor uncertainty about the 120 mg result and prior trial revisions.
Key facts
- 1The 60 mg dose met the primary endpoint of absolute change in forced vital capacity at Week 52. stocktitan.net
- 2The 120 mg dose slowed FVC decline but did not achieve statistical significance. stocktitan.net
- 3The trial enrolled approximately 1,255 adults with idiopathic pulmonary fibrosis. stocktitan.net
- 4Admilparant demonstrated a well‑tolerated safety profile with low discontinuations due to adverse events, similar to placebo. stocktitan.net
- 5Bristol Myers Squibb will engage health authorities for regulatory submissions and present detailed results at a future medical meeting. stocktitan.net
Open questions
- Material 9 states the primary endpoint was not met, contradicting the majority of sources that say it was met.
Summary written by AlphAI AI Desk from 10 of 11 sources. Not investment advice. Figures are as stated by the linked sources.