Chong Kun Dang speeds up dyslipidemia drug development

CKD-508, approved to initiate Phase 1 trial in the U.S.… 2nd-generation CETP inhibitor

Development started in 2014... second trial after the UK trial

5 clinical trials on of synthetic new drugs…also develops treatments for rare diseases and liver diseases

  Chong Kun Dang is accelerating the development of new drugs for dyslipidemia.

 

The company has received approval to initiate a second global clinical trial in 10 years for its new drug candidate 'CKD-508' since the company began its research in 2014.

 

According to industry sources on the 4th, Chong Kun Dang recently received approval from the U.S.

 

Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial on its dyslipidemia drug candidate, 'CKD-508'.

 

Through the clinical trial, Chong Kun Dang plans to verify the safety and lipid-improving effect of CKD-508 and explore the optimal dose for its future Phase 2 trial.

 

CKD-508 is a second-generation drug that overcomes the challenges of first-generation cholesteryl ester transfer protein (CETP) inhibitors, including limitations such as off-target effects (unexpected side effects caused by the drug), accumulation of fat cells, and poor stability.

 

The drug candidate works by inhibiting the activity of CETP, which facilitates the transport of cholesteryl esters (CE) and triglycerides (TG) between fatty proteins in the blood, thereby lowering low-density lipoprotein cholesterol (LDL-C) levels and raising high-density cholesterol (HDL-C) levels.

 

More than 6 years after initiating the CKD-508 study in 2014, Chong Kun Dang has now initiated global clinical trials.

 

In June 2020, the company received approval from the UK's MHRA for a Phase 1 clinical trial of CKD-508 and is advancing its research and development.

 

Preclinical results showed that CKD-508 significantly reduced LDL-C and LDL-C-containing apoprotein (Apo-B) and increased HDL-C in animal models with dyslipidemia.

 

In addition, CKD-508 did not cause drug accumulation in adipose tissue or an increase in blood pressure, which were observed in clinical trials of anacetrapib and torcetrapib.

 

Anacetrapib and torcetrapib were candidates for dyslipidemia developed by Merck and Pfizer, but the companies discontinued their development in 2017 due to safety concerns in the clinical trial stage.

 

Chong Kun Dang believes that CKD-508 has the potential to be a breakthrough drug that could provide a new treatment option for patients with dyslipidemia that is not controlled by existing drugs such as statins.

 

CKD-508 can be administered once weekly and may offer improved convenience over existing therapies.

 

Along with CKD-508, Chong Kun Dang is also conducting 5 clinical trials in the synthetic drug category, including CKD-943 for uremic pruritus, CKD-950 (namodenoson) for hepatocellular carcinoma, CKD-951 for metabolic dysfunction-associated steatohepatitis (MASH), and CKD-510 for rare diseases.

 

The company completed clinical trials for CKD-943 in the U.S.

 

in 2015 and is currently in Phase III clinical trials.

 

Chong Kun Dang has been developing CKD-943 since 2012 after signing a license agreement with  Cara Therapeutics in the US for the exclusive development and sales of CKD-943 in Korea.

 

CKD-950 recently entered Phase II clinical trials in Israel.

 

In 2016, Chong Kun Dang entered into an exclusive domestic license agreement with Israel's Can-fite Biopharma for CKD-950, a novel liver cancer drug candidate.

 

The company also acquired a domestic patent for CKD-950 in 2020.

 

CKD-951, which is being developed as a treatment for MASH, has been recruiting patients since its IND approval in 2020.

 

CKD-951 has a mechanism of action that improves inflammatory and fibrotic responses by acting on A3AR, which is overexpressed in liver inflammatory/fibrosis-promoting cells.

 

CKD-510 was licensed out to Novartis in November of last year.

 

CKD-510 is a histone deacetylase 6 (HDAC6) inhibitor that uses the company’s highly selective, non-hydroxamic acid platform technology.

 

The drug candidate has demonstrated safety and tolerability in Phase I clinical trials in the U.S.

 

and Europe.