LISCure Biosciences Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)

• Represents first ever live biotherapeutic product to receive IND clearance for PSC
• Phase 2 clinical trial will evaluate the safety and efficacy, including clinical endpoints of LB-P8

SEONGNAM, South Korea, Feb. 29, 2024 /PRNewswire/ -- LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative microbiome-based therapies, announces the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for LB-P8, a live biotherapeutic product (LBP) intended to treat primary sclerosing cholangitis (PSC). LISCure anticipates treating the first patient in the upcoming months and expects topline results for Part 1 in the first half of 2025.

PSC is a rare, chronic, cholestatic liver disease with very high unmet medical needs where there are no approved drugs. PSC can benefit from microbiome drugs because PSC is linked to the "gut-liver" axis and is strongly associated with total gastrointestinal risk and inflammatory bowel disease (IBD). LB-P8, designed to treat inflammation and fibrosis and to modulate bile acids, is expected to perform significantly well in clinical trials and hold a high position of success rate in drug development.

LISCure confirmed the safety, tolerability, and key biomarkers of LB-P8 in a Phase 1 study and received Orphan Drug Designation (ODD) for the treatment of PSC from the U.S. FDA. LB-P8 was presented in oral presentations at the American Association for the Study of Liver Diseases (AASLD) every year for the past two years.

"We are thrilled to obtain IND clearance to investigate LB-P8 for patients with PSC and are excited about the prospects of what this new class of medicines may mean for patients in need," said Hwasup Chin, Chief Executive Officer of LISCure Biosciences. "LB-P8 is receiving considerable attention from patient advocacy, physicians, companies, and other stakeholders. To meet their expectations, we will expedite development and offer new treatment opportunities to patients expeditiously."

About LISCure Biosciences

LISCure Biosciences Inc. is a clinical-stage company developing microbe-oriented new drugs based on innovative modalities for the areas of high unmet medical needs such as oncology, metabolic diseases, neurosciences, and immunology. LISCure uses a single strain, microbial-derived metabolites, and extracellular vesicles (EVs) to create "Next Generation Microbial Therapeutics" with precision targets. LISCure has its own screening platform technology based on a proprietary in-house microorganism bank and is dedicated to developing first-in-class new drugs against diseases for which existing microbiome treatments have been rarely attempted. For more information on LISCure or LISCure's clinical trials, please visit www.liscure.bio, or follow us on LinkedIn.

SOURCE LISCure Biosciences Inc.