Pliant Therapeutics Reveals Encouraging Data From Liver Disease Trial

Pliant Therapeutics Inc PLRX announced data from the INTEGRIS-PSC Phase 2a 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. 

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The trial's exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, and 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. 

The bexotegrast 160 mg dose group demonstrated an 84% reduction of the change in ELF score relative to placebo at Week 12.

Patients also showed stabilization of liver chemistry, including a dose-dependent trend in the 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. 

Pliant completed enrollment of the high-dose 320 mg dose cohort of the INTEGRIS-PSC Phase 2a trial. 

Interim 12-week data from the 320 mg dose is expected in Q1 of 2024, with 24-week data from this dose expected in mid-2024.

Price Action: PLRX shares were up 13.10% at $16.48 on the last check Tuesday.