Pliant Therapeutics Stock Sinks, Discontinues Mid-Stage Study For Lung Disorder

Core Viewpoint - Pliant Therapeutics Inc. has decided to discontinue the BEACON-IPF Phase 2b trial for bexotegrast in patients with idiopathic pulmonary fibrosis (IPF) following recommendations from the Data Safety Monitoring Board and an external expert panel [1][2]. Group 1: Trial Discontinuation - The trial was halted due to an imbalance in unadjudicated IPF-related adverse events between the treatment and placebo groups, despite early evidence of efficacy on the forced vital capacity (FVC) endpoint [2][4]. - The mean exposure duration in the BEACON-IPF trial was approximately 17 weeks, with IPF-related adverse events in both dose groups being comparable at around 10% [3][4]. - The imbalance was primarily attributed to a low IPF-related adverse event rate (below 3%) in the placebo group [3]. Group 2: Future Plans - The company plans to analyze the complete data from the BEACON-IPF trial to better understand the benefit-risk profile and therapeutic window of bexotegrast [5]. - Following the analysis, Pliant will consider additional dose-ranging Phase 2b studies with lower doses for pulmonary fibrosis and potentially explore other non-respiratory indications, including liver diseases [5]. Group 3: Other Developments - Pliant is currently enrolling the fourth of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095, both as monotherapy and in combination with pembrolizumab for solid tumors resistant to immune checkpoint inhibitors [6]. - Interim data from the first three cohorts of this trial is expected in the first quarter of 2025 [6]. - Following the announcement, PLRX stock experienced a significant decline of 51%, trading at $1.69 [6].