Curome BioSciences Co., Ltd. (hereinafter referred to as Curome BioSciences, CEO Joo-Seok Yoon, Curome BioSciences), a company specializing in the development of new drugs for rare and incurable diseases,
On the 20th, it was announced that the U.S. Food and Drug Administration (FDA) had designated 'HK-660S' as a fast track for the indication of Primary Sclerosing Cholangitis (PSC).
FDA Fast Track is a system designed to accelerate the clinical and approval process of new drugs being developed for serious diseases. When designated as Fast Track, developers can engage in closer consultation with the FDA, and if certain conditions are met, they can receive benefits such as priority review or rolling review.
HK-660S successfully confirmed human PoC in a domestic Phase 2a clinical trial last year, and the company expects that this fast-track designation will further accelerate the development speed of HK-660S.
HK-660S has already been designated as an orphan drug (ODD) by the U.S. FDA and the Korean Ministry of Food and Drug Safety, and is in the process of applying for orphan drug (ODD) designation to the European Medicines Agency (EMA) this year.
In addition, Curum Biosciences has received IND approval from the US FDA for the phase 2a protocol, and plans to complete the development of the phase 2b protocol in the first half of this year, complete IND amendment approval, and proceed with multinational phase 2b clinical trials in the US and Korea.
Primary sclerosing cholangitis is a rare liver disease in which chronic inflammation and fibrosis of the intra- and extra-hepatic and biliary tracts of unknown etiology progress, causing the bile duct walls to thicken and narrow or become stenotic. It is a disease with high unmet medical needs for which there is currently no approved treatment.
“We are pleased to have received fast-track designation for HK-660S, our core pipeline, for primary sclerosing cholangitis, a disease for which there are no approved treatments, which will allow us to accelerate the development of the treatment,” said Yoon Joo-seok, CEO of Curom Bioscience. “We will continue to make every effort to develop the treatment that can help patients suffering from rare diseases.”
Curom Biosciences, established in 2017, is a company specializing in the development of treatments for rare and intractable diseases. With the goal of becoming Korea's first new drug sales-based bio venture, it plans to apply for a technology assessment in the second half of 2025 and go public in 2026.
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