Pliant Therapeutics Halts Phase 2b/3 Idiopathic Pulmonary Fibrosis Trial Following Safety Committee Recommendation

Pliant Therapeutics has voluntarily paused enrollment and dosing in the BEACON-IPF Phase 2b/3 trial of bexotegrast for idiopathic pulmonary fibrosis1 2.

The decision was made following a recommendation from the trial's independent Data Safety Monitoring Board (DSMB) after a prespecified data review1 8.

Specific reasons for the DSMB's recommendation were not disclosed, and Pliant is currently reviewing the data to understand the rationale2 4.

Patients already enrolled in the study will remain in the trial, and blinding will be maintained to preserve trial integrity4 8.

The BEACON-IPF trial was evaluating 160-mg and 320-mg doses of bexotegrast, a dual selective inhibitor of αvß6 and αvß1 integrins1.

Prior to this setback, the trial was expected to complete enrollment of 360 patients in Q1 2025, with results anticipated in mid-20261.

Pliant has informed trial investigators and is in the process of notifying global regulatory authorities about the pause1 8.

The news caused Pliant's stock to drop significantly, with shares falling around 58% in aftermarket trading4.

This development comes despite previous positive data from earlier trials, including the INTEGRIS-IPF Phase 2a trial, which showed bexotegrast was well-tolerated and achieved statistically significant FVC increases3.

The suspension raises questions about the future of bexotegrast and may potentially delay Pliant's development timeline for the drug9.