Pliant Therapeutics Discontinues BEACON-IPF Trial Amid Safety Concerns

Pliant Therapeutics has discontinued its BEACON-IPF Phase 2b trial evaluating bexotegrast in idiopathic pulmonary fibrosis (IPF) following a data review by an independent safety board. Despite showing early evidence of efficacy in forced vital capacity (FVC) improvement, an unexpected imbalance in IPF-related adverse events between treatment and placebo groups led to the trial’s halt. Pliant noted that the placebo group had an unusually low adverse event rate, contributing to the discrepancy. The company now plans a comprehensive data analysis to assess bexotegrast’s benefit-risk profile before considering further clinical development, including potential lower-dose Phase 2b studies in pulmonary fibrosis and other conditions like liver diseases.

While the BEACON-IPF trial ends, Pliant remains committed to its broader pipeline, including its oncology asset PLN-101095. Currently in Phase 1 trials for solid tumors resistant to immune checkpoint inhibitors, the study is advancing through its fourth of five planned dose cohorts, with interim results expected in early 2025. Pliant expressed gratitude to trial investigators, research teams, and participants for their contributions and remains focused on developing innovative treatments for fibrotic and oncology-related diseases.