#South Korea #Seoul #PSC #LISCure Biosciences #LB-P8

LISCure Biosciences Begins Global Phase 2 Trial of LB-P8

In a remarkable advancement in the field of biopharmaceuticals, LISCure Biosciences has officially commenced patient dosing in a global Phase 2 clinical trial for LB-P8. This promising investigational medication targets Primary Sclerosing Cholangitis (PSC), a rare and progressive liver condition that currently has no approved treatments. The announcement was made on November 5, marking a significant milestone in the company's quest to address unmet medical needs in this challenging area.

Understanding PSC

PSC is a cholestatic liver disease characterized by inflammation and fibrosis of the bile ducts. The precise causes of PSC remain unknown, making it a particularly enigmatic condition for healthcare professionals. The absence of any approved therapeutic options has left patients with limited choices, emphasizing the critical need for innovative solutions. LB-P8 aims to change that narrative.

LB-P8: A Unique Approach

LB-P8 is designed to modulate the gut-liver axis, a novel therapeutic approach intended to suppress both inflammation and fibrosis associated with PSC. Preliminary studies, including Phase 1 clinical trials, have showcased LB-P8's safety and initial efficacy, generating optimism among researchers and patients alike. Furthermore, LB-P8 is distinguished not only by its potential to treat PSC but also by its therapeutic effects in inflammatory bowel diseases (IBD)—conditions that co-occur in nearly 80% of PSC patients. This dual-action approach gives LB-P8 a competitive edge compared to other candidates under development.

Regulatory Milestones

LISCure's journey with LB-P8 has garnered recognition from regulatory bodies. The U.S. Food and Drug Administration (FDA) granted LB-P8 Orphan Drug Designation in 2022, and in 2024 it received Fast Track Designation, reflecting its importance in addressing a critical medical need. Recently, the European Medicines Agency's Committee for Orphan Medicinal Products provided a positive opinion for LB-P8's Orphan Drug Designation, paving the way for further developments in the European market.

The Global Phase 2 Trial

The ongoing Phase 2 trial, with the ClinicalTrials.gov Identifier NCT06699121, will unfold across 28 clinical sites in the United States and Europe. This extensive study is dedicated to analyzing LB-P8's safety, tolerability, and efficacy in patients diagnosed with PSC. By engaging multiple regions, LISCure is positioning LB-P8 on a global stage where it can potentially reach a broad spectrum of patients in need.

Leadership Commentary

Hwasup Chin, CEO of LISCure, expressed his optimism regarding this initiative. "PSC presents a significant unmet medical need as there are currently no FDA-approved therapeutic solutions. This milestone represents a meaningful advancement for both patients and healthcare professionals," he stated. Furthermore, Chin highlighted the strategic vision for the company, mentioning the potential of their BBB shuttle platform ExoPN-101 alongside LB-P8, reinforcing LISCure's commitment to advancing biomedical innovation based on firm scientific foundations and thorough clinical data.

Conclusion

LISCure Biosciences' launch of the Phase 2 trial for LB-P8 represents a beacon of hope for patients grappling with PSC, underscoring the importance of innovation in the survival and quality of life for those affected by this debilitating condition. As the global trial progresses, the medical community will keenly observe the outcomes, hopeful that LB-P8 could signify a breakthrough in treating this previously untreatable condition.