Pliant Therapeutics’ Bexotegrast Meets Primary, Secondary Endpoints in Phase 2a Liver Fibrosis Trial

Pliant Therapeutics, Inc. (NASDAQ:PLRX), today announced positive data from INTEGRIS-PSC, a Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The trial 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. The trial’s exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver. Results at the initial three doses tested showed bexotegrast reduced both ELF scores and PRO-C3 levels at Week 12 at all doses relative to placebo with statistically significant differences at the 160 mg dose relative to placebo at Week 12. Patients also showed stabilization of liver chemistry, including a dose-dependent trend in reduction of alkaline phosphatase (ALP) levels, relative to placebo at Week 12. In addition, preliminary MRI imaging results suggest improved hepatocyte function and bile flow with bexotegrast 160 mg. Twelve-week interim data from the high-dose 320 mg cohort is expected in the first quarter of 2024.