Pliant Therapeutics halts lung disease drug trial following safety concerns

USA – Pliant Therapeutics, a South San Francisco-based biotechnology company, has announced the immediate suspension of its phase 2b/3 BEACON-IPF trial for idiopathic pulmonary fibrosis (IPF) due to emerging safety concerns.

The decision was made following a recommendation from the trial’s independent Data Safety Monitoring Committee (DSMC), which advised pausing both patient enrollment and dosing.

In response to this development, Pliant’s shares experienced a significant decline, dropping nearly 35% in after-hours trading.

The BEACON-IPF trial was designed to evaluate the efficacy and safety of bexotegrast, Pliant’s lead investigational drug, in patients with IPF.

Bexotegrast is a dual-selective inhibitor targeting αvβ6 and αvβ1 integrins, proteins that are found in elevated levels in the lung tissue of IPF patients and are believed to contribute to the progression of fibrosis, or scarring, characteristic of the disease.

Prior to this trial, bexotegrast had demonstrated promise in the phase 2 INTEGRIS-IPF study reported in 2023.

The specific nature of the safety signal that prompted the DSMC’s recommendation has not been disclosed.

Pliant Therapeutics has stated that it is conducting a thorough analysis to understand the underlying causes of the observed safety concerns.

The company emphasized its commitment to patient safety and the integrity of the clinical trial process, noting that it will provide updates as more information becomes available.

Idiopathic pulmonary fibrosis is a progressive and often fatal lung disease characterized by the thickening and stiffening of lung tissue, leading to a decline in respiratory function.

The condition has limited treatment options, and the development of new therapies is of significant interest within the medical community.

The company has not provided a timeline for when the trial might resume or detailed the potential impact on its broader clinical development program.

Investors and stakeholders are awaiting further communications from Pliant as the situation evolves.