Bristol Myers Squibb reported that its Phase 3 ALOFT-IPF trial met its primary endpoint with admilparant 60 mg twice daily. At Week 52, the lower dose significantly improved the change in forced vital capacity (FVC)—a measure of lung function—compared with placebo.
The higher 120 mg twice-daily dose slowed FVC decline but did not achieve statistical significance, leaving questions about why the lower dose succeeded while the higher one did not. BMS has not yet released detailed effect sizes or full trial data.
The roughly 1,255-participant trial compared both doses with placebo over at least 52 weeks. BMS described the drug as well tolerated at both doses, with adverse-event-related discontinuations low and similar to placebo.
The result could support regulatory filings, but the mixed dose findings and absence of detailed data temper the headline win. BMS said it is evaluating the results with a view to discussing them with regulators.
Admilparant, formerly known as BMS-986278, is an investigational oral LPA1 receptor antagonist. BMS is also studying it in progressive pulmonary fibrosis, with results expected in early 2027.
Sources:
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