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SEOUL, South Korea, Nov. 10, 2025 /PRNewswire/ — LISCure Biosciences (“LISCure”), a clinical-stage biopharmaceutical company, announced the initiation of patient dosing in a global Phase 2 clinical trial of LB-P8, a novel therapeutic candidate for Primary Sclerosing Cholangitis (PSC), a rare and progressive liver disease with no approved treatments on November 5 (local time in the U.S.).
LB-P8: A First in Class Candidate Targeting the Gut-Liver axis
PSC is a cholestatic liver disease of unknown etiology, characterized by inflammation and fibrosis of the bile ducts, and currently has no approved treatment options worldwide.
LB-P8, LISCure’s investigational drug, acts by modulating the gut–liver axis to suppress inflammation and fibrosis. Preclinical and Phase 1 studies have demonstrated its safety and initial efficacy. Moreover, LB-P8 has shown therapeutic effects in inflammatory bowel disease (IBD), which coexists in approximately 80% of PSC patients, giving it a differentiated competitive edge over other drug candidates currently in development.
LB-P8 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in 2022 for the treatment of PSC and was granted Fast Track Designation in 2024. Recently, the Committee for Orphan Medicinal Products (COMP) under the European Medicines Agency (EMA) issued a positive opinion for LB-P8’s ODD, paving the way for its formal designation in Europe.
The ongoing Phase 2 trial (ClinicalTrials.gov Identifier: NCT06699121) will be conducted across 28 clinical sites in the United States and Europe.. The study aims to evaluate the safety, tolerability, and efficacy of LB-P8 in patients with PSC.
Hwasup Chin, CEO of LISCure, stated, “PSC represents an area of extremely high unmet medical need, as there are currently no approved therapeutic options. This milestone marks a meaningful step forward for both patients and healthcare professionals.” He added, “Together with our other core pipeline asset, the BBB shuttle platform ExoPN-101, we aim to continue advancing as a trusted global biotech company founded on solid scientific evidence and clinical data.”
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