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LISCure Biosciences Secures FDA Fast Track Designation for LB-P8 in Primary Sclerosing Cholangitis Therapy

Saturday, March 30, 2024

LISCure Biosciences, a leading clinical-stage biopharmaceutical company focused on developing innovative microbiome-based therapies, has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for LB-P8, its investigational drug for treating primary sclerosing cholangitis (PSC). PSC is a rare, chronic liver disease with significant unmet medical needs due to the lack of approved drugs.

Fast Track designation aims to expedite the development and review process for new drugs addressing serious conditions with unmet medical needs. It allows for increased communication between the FDA and sponsors, with the goal of accelerating the delivery of new therapies to patients.

LB-P8 is currently undergoing evaluation in a Phase 2 study involving PSC patients. It is the only live biotherapeutic product in clinical development for PSC. LB-P8 received Orphan Drug Designation for PSC in 2022, and its safety and key biomarkers have been confirmed in Phase 1 trials. LISCure plans to conduct Phase 2 trials across multiple sites in the US and Europe, with preliminary results expected in early 2025. Based on these results, LISCure intends to use expedited programs to bring LB-P8 to market as quickly as possible. LB-P8 is also being developed for metabolic dysfunction-associated steatohepatitis (MASH).

Jiyoung Ahn, Head of Clinical Development at LISCure, stated, "Obtaining Fast Track designation is a significant milestone in addressing the high unmet medical need for PSC. It will facilitate the efficient development of LB-P8 by enabling close communication with the regulatory authority. Through enhanced communication with regulatory authorities, we aim to expeditiously bring forward a novel therapy option in an area with limited available treatments."



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