The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LB-P8, LISCure Biosciences’ investigational drug for the treatment of primary sclerosing cholangitis (PSC), a rare, chronic, cholestatic liver disease with significant unmet medical needs.
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 needs. Fast Track designation allows for enhanced communication between the FDA and sponsors, to accelerate the delivery of new therapeutics to patients.
LB-P8 is currently undergoing evaluation in a Phase 2 study in patients with PSC. It is the only live biotherapeutic product currently reported to be in clinical development to address the needs of individuals with PSC. LISCure will conduct the 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.”
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