Pliant Therapeutics Discontinues Phase 2b/3 Trial of Bexotegrast in Idiopathic Pulmonary Fibrosis Due to Safety Concerns

Pliant Therapeutics has discontinued the BEACON-IPF Phase 2b/3 trial evaluating bexotegrast in patients with idiopathic pulmonary fibrosis (IPF)12.

The decision was made following recommendations from the trial's independent Data Safety Monitoring Board (DSMB) and an outside expert panel12.

An imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups led to the trial's discontinuation12.

The mean exposure duration in the trial was approximately 17 weeks25.

Despite safety concerns, early evidence of efficacy on the forced vital capacity (FVC) endpoint was observed12.

The percentage of IPF-related adverse events in both dose groups (160 mg and 320 mg) was comparable at approximately 10%25.

The imbalance appears to have been driven by an unusually low (below 3%) IPF-related adverse event rate in the placebo group25.

Pliant plans to analyze the complete data from the BEACON-IPF trial and evaluate next steps for bexotegrast's development25.

The company is considering additional dose-ranging Phase 2b studies with lower doses in pulmonary fibrosis and potentially other non-respiratory indications, including liver diseases25.

Pliant's stock dropped significantly (49%) following the announcement of the trial discontinuation1.

Sources:

1. https://www.fiercebiotech.com/biotech/pliant-discontinues-late-stage-lung-disease-trial-lead-asset-after-safety-review

2. https://www.globenewswire.com/news-release/2025/03/03/3035743/0/en/Pliant-Therapeutics-Provides-Update-on-BEACON-IPF-a-Phase-2b-3-Trial-in-Patients-with-Idiopathic-Pulmonary-Fibrosis.html

5. https://ir.pliantrx.com/news-releases/news-release-details/pliant-therapeutics-provides-update-beacon-ipf-phase-2b3-trial-0