Pliant Therapeutics Discontinues Development Of Bexotegrast In Idiopathic Pulmonary Fibrosis After BEACON-IPF Phase 2b/3 Clinical Trial Review

Bexotegrast development in IPF discontinued

Clinical oncology program and early-stage programs continue

Recent workforce and operational changes align with next steps

SOUTH SAN FRANCISCO, Calif., June 27, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX) today announced that following the review of data from the recently terminated BEACON-IPF Phase 2b/3 clinical trial, the Company has discontinued development of bexotegrast in idiopathic pulmonary fibrosis (IPF).

BEACON-IPF Trial Update

BEACON-IPF was a randomized, double-blind, placebo-controlled, global Phase 2b/3 clinical trial evaluating patients with IPF. In March of this year, Pliant announced the voluntary discontinuation of BEACON-IPF following a prespecified data review and recommendation by the trial's independent Data Safety Monitoring Board (DSMB), as well as a secondary review and recommendation by an outside expert panel, citing an imbalance in IPF-related adverse events.

Following an analysis of the full safety and efficacy data from the BEACON-IPF trial, the Company is discontinuing development of bexotegrast in IPF. Results showed that at doses of 160 mg and 320 mg, bexotegrast demonstrated an unfavorable risk-benefit profile. Compared to placebo, bexotegrast-treated participants showed an increased risk of experiencing adverse events associated with IPF disease progression, defined as events of worsening of IPF and acute IPF exacerbation, respiratory-related hospitalization, and/or all-cause mortality. The average time to disease progression for bexotegrast-treated participants was 33 weeks, suggesting that the safety risk may not be apparent with shorter dosing duration as was the case in the prior INTEGRIS-IPF Phase 2a trial. 

At Week 12, bexotegrast 160 mg and 320 mg treatment groups demonstrated improvements in forced vital capacity (FVC) decline of 72 mL (p<0.05) and 46 mL (p>0.05), respectively, compared to placebo. At Week 24, bexotegrast 160 mg and 320 mg treatment groups demonstrated improvements in FVC decline of 58 mL (p>0.05) and 8 mL (p>0.05), respectively, compared to placebo.

The full results from BEACON-IPF will be submitted for future publication.

Oncology Phase 1 Enrollment Continues

PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins, designed to block TGF-β activation in the tumor microenvironment. PLN-101095 is currently undergoing a Phase 1 open-label trial as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. In March, the Company announced interim results from this trial showing that PLN-101095 was generally well tolerated with confirmed partial responses in 50% of patients at highest dose tested to date, across multiple tumor types. The trial is currently enrolling the fifth of five planned dose cohorts.

Early Programs Supported by Proprietary Platform

The Company's drug discovery platform consists of a proprietary library of over 15,000 integrin binding molecules, a comprehensive screening assay system (binding, integrin confirmation, ligand-induced internalization) and an advanced live human tissue program. The Company believes in the broad applicability of the platform across multiple disease areas including delivery of drug payloads to cells utilizing integrin receptor-binding molecules as tissue-specific delivery and internalization mechanisms.