LB-P8

LB-P8 is an orally administered, once-daily, live biotherapeutic product (LBP) being developed by LISCure Biosciences. [10] It is composed of a single microbial strain, Leuconostoc citreum, which is commonly found in the fermented Korean food, kimchi. [3, 16] The drug is designed to treat inflammatory and fibrotic diseases by modulating the gut-liver axis. [9, 10] Its proposed mechanism of action involves the inhibition of the TGF-β/SMAD signaling pathway, which reduces fibroblast activation and the accumulation of inflammatory macrophages. [8] LB-P8 is primarily being investigated for the treatment of primary sclerosing cholangitis (PSC), a rare, chronic liver disease with no approved therapies. [6] It is currently in a global Phase 2 clinical trial for this indication and has been granted both Orphan Drug Designation (2022) and Fast Track Designation (2024) by the U.S. FDA. [3, 6, 9] The drug is also in development for metabolic dysfunction-associated steatohepatitis (MASH) and has shown potential in preclinical models of inflammatory bowel disease (IBD). [10]