Pliant Therapeutics Inc announced encouraging findings 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 successfully achieved its primary and secondary goals, demonstrating the safety and tolerability of bexotegrast over a 12-week treatment period, and observing a dose-dependent increase in plasma concentrations.
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The trial’s efficacy endpoints evaluated changes in liver fibrosis markers, including the Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver.
Results from the initial three tested doses demonstrated that bexotegrast led to a significant reduction in ELF scores and PRO-C3 levels at Week 12, compared to placebo. The 160 mg dose showed statistically significant differences compared to placebo.
The group receiving the 160 mg dose experienced an 84% reduction in the change in ELF score relative to the placebo at Week 12.
Patients also showed stabilization of liver chemistry, with a dose-dependent trend in the reduction of alkaline phosphatase (ALP) levels at Week 12, relative to placebo.
Additionally, preliminary MRI imaging results suggest improved hepatocyte function and bile flow in the group receiving the 160 mg dose of bexotegrast.
Pliant Therapeutics has completed enrollment of the high-dose 320 mg dose cohort for 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 expected in mid-2024.
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