Pliant Therapeutics, Inc. announced 12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical 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. The 320 mg group enrolled 27 patients in the active arm and added 9 new patients to the pooled placebo arm.

The company believe INTEGRIS- PSC to be the first randomized clinical trial to use an enrichment strategy to enroll patients with suspected moderate to severe liver fib fibrosis based on liver stiffness measure, ELF score or historical liver biopsy. Baseline characteristics of the trial population reflected this enrichment. ELF score - Change from Baseline at Week 12: Consistent with the lower doses tested, bexotegrast at 320 mg reduced ELF score relative to placebo at Week 12.

The ELF score is a well-established prognostic marker of liver disease severity and liver-related events in patients with advanced fibrosis. ELF is strongly associated with transplant-free survival in PSC and may be useful as a surrogate marker in clinical trials. Consistent with the lower dose tested, bexotegrAST at 320 mg reduced PRO-C3 levels relative to placebo.

PRO-C3 is a biomarker of active fibrogenesis with higher levels associated with greater disease activity. MRI relative enhancement using gadoxetate contrast is a measure of hepatocyte function, with increased enhancement suggesting improved hepatocyte function. Consistent with the lower doses testing, bexotegrast At the 320 mg dose showed an increase in relative enhancement on contrast MRI compared to a decrease observed in the placebo group at Week 12.

Special thanks to the INTEGRIS-PSc clinical trial participants, their families and support networks for helping advance this promising program. Background on Primary Sclerosing Cholangitis: PSC is a rare, progressive liver disease of unknown origin, which frequently occurs in the setting of inflammatory bowel disease. PSC is characterized by inflammation and fibrosis, with progressive liver and biliary damage leading to cirrhosis and liver failure.

Currently there are no FDA or EMA-approved therapies for patients with PSC. Therefore, there is a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this devastatingous illness. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation From the European Medicines Agency in IPF and PSC.

Pliant has initiated a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of avss8 and avss1 integrins, that is being developed for the treatment of solid tumors. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of product candidates, including any delays in ongoing or planned preclinical or clinical clinical or clinical trials.