LISCure Biosciences receives U.S. FDA Fast Track designation for LB-P8 for the treatment of primary sclerosing cholangitis (PSC)

29 Mar 2024
www.prnewswire.com
Fast TrackPhase 2Orphan DrugMicrobial therapyPhase 1
Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be in clinical development for the treatment of PSC
FDA's Fast Track designation for LB-P8 underlines the urgent need for treatment options to fulfill the unmet medical needs of people affected by PSC
SEONGNAM, South Korea, March 29, 2024 /PRNewswire/ -- LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on discovering and developing innovative microbiome-based therapies, 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.
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.
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 US and Europe. The preliminary results are expected in early 2025. Based on these results, LISCure will make maximum use of expedited programs to bring LB-P8 to market as quickly as possible. LB-P8 is also being developed for metabolic dysfunction-associated steatohepatitis (MASH).
"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. "By having enhanced communication with the regulatory authority, we will expeditiously bring forward a novel therapy option in an area with limited available treatments."
LISCure Biosciences Inc. is a clinical-stage company developing microbe-oriented new drugs and drug delivery platforms based on innovative modalities for the areas with high unmet medical needs such as oncology, metabolic diseases, neurosciences, and immunology. LISCure uses single strain, microbial-derived metabolites, and extracellular vesicles (EVs) to create "Next Generation Microbial Therapeutics" and "EV-based Drug Delivery Platforms". 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. For more information on LISCure or LISCure's clinical trials, please visit www.liscure.bio, or follow us on LinkedIn.
SOURCE LISCure Biosciences Inc.
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