Summation
- “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.
- 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.
- 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.
LB-P8
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
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.
Phase 2 Study
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).
Jiyoung Ahn, Head of Clinical Development, LISCure
“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. By having enhanced communication with the regulatory authority, we will expeditiously bring forward a novel therapy option in an area with limited available treatments.”
