FDA Grants Fast Track Designation for LISCure’s LB-P8 for the Treatment of PSC

Rare Daily Staff

The U.S. Food and Drug Administration has granted Fast Track designation for LISCure Biosciences’ LB-P8, an experimental drug for the treatment of the rare and progressive liver disease primary sclerosing cholangitis.

Primary sclerosing cholangitis (PSC) is characterized by inflammation and destruction of the intra- and/or extra-hepatic bile ducts that lead to cholestasis liver fibrosis liver cirrhosis and ultimately liver failure. Currently there are no approved drugs available to treat it.

Fast Track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical need. Fast Track designation allows for enhanced communication between the FDA and sponsors, with the goal of accelerating the delivery of new therapeutics to patients.

Korean biotech LISCure uses single strain, microbial-derived metabolites and extracellular vesicles to create therapies using its own screening platform technology based on a proprietary in-house microorganism bank to target areas of unmet medical need.

LB-P8 is currently undergoing evaluation in a phase 2 study in patients with PSC. LB-P8 is the only live biotherapeutic product currently reported to be in clinical development to address the needs of individuals with PSC. LB-P8 was granted Orphan Drug Designation for PSC in 2022, and the safety and key biomarkers of LB-P8 have been confirmed in phase 1 study. LISCure will conduct phase 2 study in multiple sites across the U.S. and Europe with preliminary results expected in early 2025. LB-P8 is also being developed for metabolic dysfunction-associated steatohepatitis.

“Receiving Fast Track designation is a significant milestone in addressing the high unmet medical need for PSC, and it will facilitate the efficient development of LB-P8 by enabling close communication with the regulatory authority,” said Jiyoung Ahn, head of Clinical Development, LISCure.