Chong Kun Dang’s cholesterol drug approved for Phase 1 trial in U.S.

(Chong Kun Dang)

South Korea’s Chong Kun Dang (CKD) announced Monday that it has received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial for its cholesterol treatment drug, CKD-508. The drug, designed to treat dyslipidemia, works by inhibiting the activity of Cholesteryl Ester Transfer Protein (CETP), thereby lowering low-density lipoprotein cholesterol (LDL-C) and raising high-density lipoprotein cholesterol (HDL-C).

During this trial, Chong Kun Dang aims to assess both the safety and lipid-lowering effects of CKD-508, as well as to determine the optimal dosage for the next phase of clinical testing. Preclinical studies have shown the drug’s effectiveness in reducing LDL-C and increasing HDL-C levels. Additionally, a significant reduction in apolipoprotein B (Apo-B), a key indicator of dyslipidemia, was observed.

The company explained that CKD-508’s strong binding affinity to CETP addresses issues that halted development of previous CETP inhibitors, such as drug accumulation and increased blood pressure. Due to its potency, CKD-508 may prove effective at lower doses. If successful, the drug could offer a new treatment option for patients with dyslipidemia unresponsive to statins, a widely used cholesterol-lowering drug class.

The global market for dyslipidemia treatments, currently valued at $8 billion, is expected to grow to $20 billion by 2030.