Workflow
Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis
PLRXPliant Therapeutics(PLRX) GlobeNewswire·2025-02-13 13:00

Core Insights - Pliant Therapeutics has initiated the assembly of an outside expert panel to review unblinded data from the BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) [1] - The decision to form this panel follows the Data Safety Monitoring Board's (DSMB) recommendation to pause enrollment and dosing in the trial, as the company could not determine the rationale for this recommendation through blinded data [2] - The expert panel will provide independent recommendations and will be part of an expanded DSMB to reach a consensus regarding the BEACON-IPF trial [1] Company Overview - Pliant Therapeutics is a late-stage biopharmaceutical company focused on developing novel therapeutics for fibrotic diseases, with its lead product candidate being bexotegrast [3] - Bexotegrast is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins, currently in development for the treatment of IPF [3] - The company has received Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation from the European Medicines Agency for bexotegrast in IPF [3] - Pliant is also conducting a Phase 1 study for another clinical program, PLN-101095, targeting solid tumors, and has received regulatory clearance for a Phase 1 study of PLN-101325 for muscular dystrophies [3]