The US Food and Drug Administration (FDA) has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of primary sclerosing cholangitis (PSC).
With the designation, the company will fast track the development of the drug to fulfill the unmet medical needs of people affected by PSC.
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LB-P8 is designed to treat inflammation and fibrosis as well as to modulate bile acids.
LISCure said the LB-P8 live biotherapeutic product (LBP) is the only one of its kind reported to be in clinical development for PSC, a rare and chronic liver disease with no approved treatment options.
The drug previously received orphan drug designation for PSC in 2022.
Its safety and key biomarkers have been confirmed in a Phase I study.
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By GlobalDataLISCure plans to conduct a Phase II study across multiple sites in the US and Europe, with preliminary results expected in early 2025.
It is also under development for metabolic dysfunction-associated steatohepatitis (MASH).
LISCure clinical development head Jiyoung Ahn said: “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.”
Earlier this year, LISCure secured FDA’s clearance of its Investigational New Drug (IND) application for LB-P8.
In the upcoming months, the company plans to treat the first patient and expects topline results for Part 1 in the first half of 2025.
