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Thursday, February 13, 2025

Pliant Next Steps After DSMB Recommendation on Phase 2b/3 in Idiopathic Pulmonary Fibrosis

 Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that, per the charter of the trial’s independent Data Safety Monitoring Board (DSMB), the Company has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The panel, consisting of world-renowned experts in pulmonary diseases and biostatistics, will provide an independent recommendation to Pliant regarding the BEACON-IPF trial. Subsequently, the panel will serve as part of an expanded DSMB with the goal to reach a consensus recommendation regarding BEACON-IPF. The decision to assemble the outside panel was taken as the Company has not been able, through review of blinded data, to determine the rationale for the DSMB’s recommendation to pause enrollment and dosing in the trial. The Company expects this process to conclude in two to four weeks.

Following the DSMB’s previously announced recommendation, Pliant voluntarily paused enrollment and dosing in the BEACON-IPF clinical trial. Pliant is committed to remaining blinded ensuring the data integrity of the BEACON-IPF 2b clinical trial with the goal of maintaining its potential to serve as a registrational trial.

https://www.globenewswire.com/news-release/2025/02/13/3025849/0/en/Pliant-Therapeutics-Announces-Next-Steps-Following-DSMB-Recommendation-on-BEACON-IPF-a-Phase-2b-3-Trial-in-Patients-with-Idiopathic-Pulmonary-Fibrosis.html

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