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Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from Phase 2a INTEGRIS-PSC Clinical Trial of Bexotegrast in Patients with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis
Bexotegrast (PLN-74809) was well tolerated over 12 weeks of treatment with few discontinuations and no drug-related severe or serious adverse events
About this update from Pliant Therapeutics, Inc.
[{"type":"text","content":"Bexotegrast (PLN-74809) was well tolerated over 12 weeks of treatment with few discontinuations and no drug-related severe or serious adverse events Bexotegrast reduced both the Enhanced Liver Fibrosis (ELF) score and collagen synthesis biomarker PRO-C3 levels relative to placebo at all doses with statistical significance at the 160 mg dose Bexotegrast-treated patients showed improved liver biochemistry and imaging parameters relative to placebo at Week 12 Company to host webcast and conference call today, Tuesday, September 26 at 8:00 a.m. ET SOUTH SAN FRANCISCO, Calif., Sept. 26, 2023 (GLOBE NEWSWIRE) -- 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. INTEGRIS-PSC is a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a trial evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 85 patients with PSC. 64 patients were enrolled in the active arms and 21 patients were enrolled in the placebo arm. We believe INTEGRIS-PSC to be the first randomized clinical trial to use an enrichment strategy to enroll patients with suspected moderate to severe liver fibro...