LB-P8 / LISCure Biosci, Mayo Clinic - LARVOL DELTA

A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC (clinicaltrials.gov) - P2 | N=87 | Recruiting | Sponsor: LISCure Biosciences | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2025 ➔ Nov 2025

Enrollment open • Trial initiation date

A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC (clinicaltrials.gov) - P2 | N=87 | Not yet recruiting | Sponsor: LISCure Biosciences

New P2 trial • Hepatology

LISCure Biosciences receives U.S. FDA Fast Track designation for LB-P8 for the treatment of primary sclerosing cholangitis (PSC) (PRNewswire) - "LISCure Biosciences...announces the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LB-P8, LISCure's investigational drug for the treatment of primary sclerosing cholangitis (PSC). PSC is a rare, chronic, cholestatic liver disease with significant unmet medical needs as there are no approved drugs available to treat it....LISCure will conduct Phase 2 study in multiple sites across the US and Europe. The preliminary results are expected in early 2025."

Fast track designation • P2 data • Trial status • Immunology • Primary Biliary Cholangitis

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

IND • New P2 trial • P2 data • Inflammation

LEUCONOSTOC SP. LB-P8 AMELIORATES LIVER INFLAMMATION AND FIBROSIS IN DIET-INDUCED NON-ALCOHOLIC STEATOHEPATITIS (AASLD 2022) - "LB-P8 ameliorates NASH progression by modulating the intrahepatic macrophage population, stellate cell activation, and gut bacteria profile. These data suggest that LB-P8 targeting of the gut-liver axis could be a potential novel therapeutic strategy for the treatment of NASH."

Fibrosis • Hepatology • Immunology • Inflammation • Liver Failure • Non-alcoholic Steatohepatitis • CASP3 • IL1B • IRF5 • MRC1 • TNFA

A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: LISCure Biosciences | Recruiting ➔ Completed

Trial completion • Hepatology • Immunology • Inflammatory Arthritis • Non-alcoholic Steatohepatitis • Rheumatoid Arthritis • Rheumatology

A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: LISCure Biosciences; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2022 ➔ Jun 2022; Trial primary completion date: Nov 2021 ➔ Apr 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Hepatology • Immunology • Inflammatory Arthritis • Non-alcoholic Steatohepatitis • Rheumatoid Arthritis • Rheumatology