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# Pliant Pauses Bexotegrast Trial for Safety Review
- URL: https://www.fdaweb.com/pliant-pauses-bexotegrast-trial-for-safety-review/
- Published: 2025-02-10T12:00:00.000Z
- Updated: 2026-09-14T14:52:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158630

Pliant Therapeutics says it has paused enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The pause was recommended following a prespecified data review by the trial’s independent data safety monitoring board.

The company says the pause will last until the data are reviewed to understand the safety board’s rationale for their recommendation. “Blinding of the study will be maintained to preserve trial integrity,” it says, adding that clinical trial investigators and global regulatory authorities are being updated on the action.

Pliant's lead product candidate, bexotegrast, is described as an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development for treating IPF. The drug has received an Fast Track Designation and Orphan Drug Designation from FDA.