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Curome Biosciences`s HK-660S Receives U.S. FDA Orphan Drug Designation for Treatment of Primary Sclerosing Cholangitis

관리자 2022.04.01

HK-660S, a novel treatment for primary sclerosing cholangitis (PSC) developed by South Korean biotech company Curome Biosciences Co., has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA).

PSC is a rare chronic progressive cholestatic liver disease characterized by inflammation and fibrosis of the bile ducts. The bile ducts inside and outside of the liver are eventually blocked or narrowed, leading to the accumulation of bile acids in the liver and, consequently, inflammation and fibrosis of liver cells. The cause of PSC remains unknown and no medication has proven to be effective yet.

Curome Biosciences`s HK-660S (generic name: Beta-Lapachone) is a nicotinamide adenine dinucleotide (NAD+) booster that is an anti-inflammatory and anti-fibrotic oral treatment by increasing intracellular NAD+ levels. In the PSC animal models assessing the efficacy of HK-660S, the administration of the drug lowered serum alkaline phosphatase (ALP), a biomarker for PSC, and exhibited anti-inflammatory and anti-fibrotic effects in the liver tissue.

Jooseog Yoon, CEO of Curome Biosciences, said: "The ODD approval of HK-660S by the U.S. FDA confirmed the potential for development as a treatment for PSC. We hope that we will be able to provide a treatment to patients with PSC as soon as possible."

[Source: Curome Biosciences Co.]

[Source: Curome Biosciences Co.]

With the FDA`s ODD, the Korean biotech company will receive FDA support for the development of its novel PSC therapy. The FDA provides various incentives such as tax credits, exemption from user fees, and potential seven years of market exclusivity after approval to developers of ODD drugs for the treatment of rare diseases.

Curome Biosciences is currently conducting Phase 2 clinical trials for the treatment of PSC at two large hospitals in Seoul, Korea after receiving investigational new drug (IND) approval from the country`s Ministry of Food and Drug Safety and registering its first subject last year.

By Susan Lee

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