来源: Pharmaceutical Technology
LISCure expects Phase II study preliminary results in early 2025. Credit: BlurryMe/Shutterstock.com. With the designation, the company will fast track the development of the drug to fulfill the unmet medical needs of people affected by PSC. 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.
来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
Its safety and key biomarkers have been confirmed in a Phase I study.
LISCure plans to conduct a Phase II study across multiple sites in the US and Europe, with preliminary results expected in early 2025.
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.