Pliant Therapeutics Pauses Lead Product Mid-Stage Trial

 Pliant Therapeutics, Inc. (NASDAQ:PLRX) stock is trading lower on Monday.

On Friday, during after-hours trading, Pliant Therapeutics announced it has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF), a chronic lung disease that causes scarring and stiffening of the lung tissue.

Patients currently enrolled in BEACON-IPF will remain in the trial.

The move follows a prespecified data review and recommendations by the trial’s independent Data Safety Monitoring Board.

Enrollment and dosing have been paused while data are reviewed to understand the DSMB’s rationale for their recommendation. The study will be blinded to preserve trial integrity.

In May 2024, On Tuesday, Pliant Therapeutics announced topline data from a Phase 2a PET Imaging trial of bexotegrast (PLN-74809) evaluating change in total collagen levels in the lungs of patients with idiopathic pulmonary fibrosis (IPF) characterized by excessive collagen deposition in the lung.

Bexotegrast-treated patients showed reduced total lung collagen post-treatment as measured by positron emission tomography (PET) imaging, compared to increased total lung collagen in the placebo group, suggesting potential reversal of fibrosis.

Last February, Pliant Therapeutics released 12-week interim data from the 320 mg dose group of INTEGRIS-PSC Phase 2a trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis.

The 320 mg group met its primary and secondary endpoints, demonstrating that bexotegrast was well tolerated over a 12-week treatment period, and its plasma concentrations increased with dose.

There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.

https://finance.yahoo.com/news/pliant-therapeutics-pauses-lead-product-133204055.html