- 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."
About LISCure Biosciences
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.
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content:https://www.prnewswire.com/news-releases/liscure-biosciences-receives-us-fda-fast-track-designation-for-lb-p8-for-the-treatment-of-primary-sclerosing-cholangitis-psc-302102626.html
SOURCE LISCure Biosciences Inc.