LISCure Biosciences Launches Phase 2 Trial of First-in-Class LB-P8 for Primary Sclerosing Cholangitis
核心洞察
LISCure Biosciences (搜索) initiated patient dosing in a global Phase 2 clinical trial of LB-P8, a novel therapeutic candidate targeting Primary Sclerosing Cholangitis (搜索) (PSC (搜索)), a rare liver disease with no approved treatments.
LB-P8 represents a first-in-class approach that modulates the gut-liver axis (搜索) to suppress inflammation and fibrosis, with demonstrated safety and initial efficacy in preclinical and Phase 1 studies.
The investigational drug has received multiple regulatory designations including FDA Orphan Drug Designation in 2022, Fast Track Designation in 2024, and a positive opinion for European Orphan Drug Designation.
LISCure Biosciences (搜索), a clinical-stage biopharmaceutical company, announced on November 10, 2025, the initiation of patient dosing in a global Phase 2 clinical trial of LB-P8 for Primary Sclerosing Cholangitis (搜索) (PSC (搜索)). The milestone represents a significant advancement in addressing a rare and progressive liver disease that currently has no approved treatment options worldwide.
Novel Mechanism Targets Gut-Liver Axis
PSC (搜索) is a cholestatic liver disease (搜索) of unknown etiology, characterized by inflammation and fibrosis of the bile ducts. LB-P8, LISCure (搜索)'s investigational drug, acts by modulating the gut-liver axis (搜索) to suppress inflammation and fibrosis, representing a first-in-class therapeutic approach.
Preclinical and Phase 1 studies have demonstrated LB-P8's safety and initial efficacy. The drug candidate has shown therapeutic effects in inflammatory bowel disease (搜索) (IBD (搜索)), which coexists in approximately 80% of PSC (搜索) patients, providing a differentiated competitive edge over other drug candidates currently in development.
Regulatory Recognition and Fast Track Status
LB-P8 has received significant regulatory recognition for its potential to address unmet medical needs. The U.S. Food and Drug Administration (FDA) granted the drug Orphan Drug Designation (ODD) in 2022 for the treatment of PSC (搜索), followed by 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.
Global Phase 2 Trial Design
The ongoing Phase 2 trial, registered under 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 (搜索).
Patient dosing began on November 5, 2025, marking a critical step in the clinical development program for this first-in-class therapeutic candidate.
Addressing Critical Unmet Medical Need
"PSC (搜索) represents an area of extremely high unmet medical need, as there are currently no approved therapeutic options," stated Hwasup Chin, CEO of LISCure (搜索). "This milestone marks a meaningful step forward for both patients and healthcare professionals."
Chin emphasized the company's broader strategic vision, adding, "Together with our other core pipeline asset, the BBB shuttle platform ExoPN-101 (搜索), we aim to continue advancing as a trusted global biotech company founded on solid scientific evidence and clinical data."