Primary-source record
Decision-gradeTopline results
BMY Admilparant Phase 3 ALOFT-IPF Trial Meets Primary Endpoint in IPF
The Phase 3 ALOFT-IPF trial met its primary endpoint of statistically significant improvement in absolute change in FVC from baseline to Week 52 at the 60 mg twice-daily dose versus placebo; the 120 mg dose slowed FVC decline but did not reach statistical significance. Admilparant showed a favorable safety profile with low adverse-event discontinuations comparable to placebo. BMS will evaluate full data, engage regulators for planned submissions, and present detailed results at a future medical meeting; ALOFT-PPF topline remains expected in early 2027.
Key facts
- Filed
- Oct 12, 2026, 10:50 AM
- Event
- Topline results
- Direction
- Positive
- Company
BMYBristol-Myers Squibb- Asset
- admilparant
- Source
- Company press release
- Confidence
- Sourced
- safety
- well-tolerated, low discontinuations similar to placebo
- fvc 120mg
- slowed decline but not statistically significant
- fvc change
- statistically significant at 60 mg vs placebo
Source excerpt
Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint In the trial, admilparant at the 60 mg dose demonstrated a statistically significant benefit in absolute change in forced vital capacity (FVC) from baseline to Week 52 compared with placebo Admilparant demonstrated a favorable safety and tolerability profile The totality of the findings supports the potential of admilparant as a clinically meaningful first-in-class treatment Bristol Myers Squibb (NYSE: BMY) today announced topline results from the pivotal Phase 3 ALOFT-IPF trial evaluating the efficacy, safety and tolerability of admilparant, a potential first-in-class, orally administered, potent and selective lysophosphatidic acid receptor 1 (LPA 1 ) antagonist, in adults with idiopathic pulmonary fibrosis (IPF). The trial evaluated two dose levels of admilparant, 60 mg and 120 mg, twice daily for ≥52 weeks against placebo (1:1:1). The trial met its primary endpoint at the 60 mg dose, with admilparant demonstrating a statistically significant improvement compared to placebo in absolute change in forced vital capacity (FVC) from baseline at