US FDA approves IND for phase 1 clinical trial of ‘CKD-508’
Non-clinical evidence confirms reduction in bad cholesterol levels
Phase 1 clinical trial underway in the UK… IND approval in 2020
Chong Kun Dang announced on the 4th that it has received approval from the U.S. Food and Drug Administration (FDA) for the U.S. Phase 1 clinical trial (IND) for the new dyslipidemia treatment drug ’CKD-508′.
CKD-508 inhibits the activity of cholesterol ester transfer protein (CETP), which promotes the transport of cholesterol ester (CE) and triglycerides (TG) between lipoproteins in the blood. Through this, it has a mechanism to lower the level of low-density cholesterol (LDL-C), known as ‘bad cholesterol’, and increase the level of high-density cholesterol (HDL-C). The effectiveness was confirmed in a non-clinical efficacy test conducted at Chong Kun Dang Hyojong Research Institute, and it was demonstrated that apoprotein (Apo-B), a major indicator of dyslipidemia, was significantly reduced.
Dyslipidemia refers to a state in which LDL-C and triglycerides in the blood are increased or HDL-C is decreased. The disease can occur due to factors such as obesity, diabetes, and drinking, and is one of the risk factors for cardiovascular disease.
Chong Kun Dang plans to confirm the safety and lipid improvement effect through phase 1 clinical trials in the U.S. and explore the optimal dosage for phase 2 clinical trials. In the UK, the phase 1 clinical trial plan was approved in June 2020 and clinical trials began first.
A Chong Kun Dang official said, “CKD-508 is an innovative drug that can be expected to be effective even at low doses by solving the problems of existing CETP inhibitors, whose development was discontinued due to problems such as drug accumulation and increased blood pressure, based on its strong binding to CETP.” “We expect it to be a new treatment option for patients with dyslipidemia that cannot be controlled with drugs in the (synthetic inhibitor) class,” he said.
According to Chong Kun Dang, the global dyslipidemia treatment market size is expected to grow significantly from about 11 trillion won currently to about 27.5 trillion won in 2030.
Kim Min-beom, Donga.com reporter [email protected]
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Chong Kun Dang recently announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial (Investigational New Drug application) of their new treatment for dyslipidemia, named ‘CKD-508’. This drug is designed to inhibit the activity of cholesterol ester transfer protein (CETP), which plays a role in the transport of cholesterol esters and triglycerides. The mechanism of action for CKD-508 aims to decrease levels of low-density cholesterol (LDL-C), recognized as “bad cholesterol,” while increasing high-density cholesterol (HDL-C), often referred to as “good cholesterol.”
Preliminary non-clinical efficacy tests conducted at the Chong Kun Dang Hyojong Research Institute have demonstrated a significant reduction in apoprotein (Apo-B), which is a crucial indicator of dyslipidemia. Dyslipidemia is characterized by elevated LDL-C and triglycerides or diminished HDL-C levels in the blood, conditions often linked to obesity, diabetes, and alcohol consumption, and acknowledged as significant risk factors for cardiovascular diseases.
Chong Kun Dang intends to assess CKD-508’s safety and lipid-lowering effects during the U.S. Phase 1 clinical trials, alongside determining the optimal dosage for subsequent Phase 2 trials. The drug’s Phase 1 trial plan received approval in the UK in June 2020, where the clinical trials commenced first.
A representative from Chong Kun Dang emphasized that CKD-508 represents an innovative approach to treating dyslipidemia, particularly highlighting its potential efficacy at low doses and the resolution of issues faced by existing CETP inhibitors, which have generally been shelved due to complications like adverse drug reactions and elevated blood pressure.
Moreover, Chong Kun Dang anticipates substantial growth in the global dyslipidemia treatment market, with projections estimating an increase from approximately 11 trillion won to about 27.5 trillion won by 2030.