LISCure Biosciences' LB-P8 Granted Fast Track Designation by FDA for Primary Sclerosing Cholangitis Treatment

01 April 2024 | Monday | News

Breakthrough Microbiome-Based Therapy for Rare Liver Disease Advances Toward Approval, Promising Hope for Patients with Limited Treatment Options
Image Source | Public Domain

Image Source | Public Domain

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."

Survey Box

Poll of the Week

Which area of biopharmaceutical research excites you the most?

× Please select an option to participate in the poll.
× You have successfully cast your vote.
 {{ optionDetail.option }}  {{ optionDetail.percentage }}%
 {{ optionDetail.percentage }}% Complete
More polls
Stay Connected

Sign up to our free newsletter and get the latest news sent direct to your inbox

© 2024 Biopharma Boardroom. All Rights Reserved.


Forgot your password?



Lost your password? Please enter your email address. You will receive a link to create a new password.

Back to log-in