After Big Pharma flops, Chong Kun Dang reopens CETP race with US trial

After Eli Lilly, Pfizer, and MSD (Merck & Co. in the U.S. and Canada) walked away from CETP inhibition, Korean pharma Chong Kun Dang is stepping in with a bet on dyslipidemia, a condition marked by abnormal cholesterol and triglyceride levels.

The company has launched a U.S. phase 1 trial of CKD-508, a second-generation cholesteryl ester transfer protein (CETP) inhibitor designed to avoid the pitfalls that sank earlier efforts, including drug accumulation and blood pressure spikes.

The study, registered in May following FDA clearance last November, will recruit 24 healthy adult men at a site in Glendale, California. Its objective is to assess pharmacokinetics and drug–drug interactions with the sedative midazolam and the cholesterol-lowering statin rosuvastatin, both of which are metabolized through CYP3A. The 24-day regimen is expected to wrap by Aug. 16.

CKD-508 is a new generation CETP inhibitor. The drug features “tighter CETP binding and greater specificity,” the company said in a November release, and is designed to overcome the failures of earlier drugs.

Preclinical studies from the company’s Hyojong research institute showed “clear reductions in LDL-C, increases in HDL-C, and marked drops in Apo-B,” a key marker in dyslipidemia.

While the company declined to share updated data, it said the drug’s profile “allows for therapeutic effects even at low doses” and could offer a new option for statin-resistant patients.

CKD-508 is also being tested in a separate U.K. phase 1 trial, initiated in January 2024, targeting dyslipidemia in healthy adults. Development is ongoing.

Chong Kun Dang isn’t alone this round. Netherlands-based NewAmsterdam Pharma, which picked up obicetrapib from Amgen, reported positive topline data Monday from a prespecified Alzheimer’s biomarker sub-study in its phase 3 BROADWAY trial.

Originally designed to test LDL-C lowering in ASCVD, a form of artery-hardening heart disease, and HeFH, a genetic cholesterol disorder, the trial now suggests CETP inhibition could extend into neurodegeneration.

CEO Michael Davidson said the findings “further differentiate obicetrapib” and underscore CETP’s potential role in Alzheimer’s prevention as well as heart disease. With more than 800 patients treated so far, GlobalData estimates obicetrapib is on track to become the first CETP inhibitor to reach the market and projects sales could hit $1.4 billion by 2032.

But that path is littered with billion-dollar casualties. Pfizer poured nearly $1  billion into torcetrapib before pulling it in 2006 due to excess mortality. Lilly spent hundreds of millions on evacetrapib before nixing it in 2015.

Merck came closest with anacetrapib, which modestly reduced coronary events but failed on key secondary endpoints and was scrapped in 2017. Amgen, too, shelved its $1.55 billion CETP bet after acquiring Dezima’s obicetrapib predecessor, AMG 899.

DalCor remains the last late-stage holdout, advancing dalcetrapib, an HDL-raising CETP inhibitor previously shelved by Roche, in a genotype-guided phase 3 trial for post-acute coronary syndrome patients with ADCY9 variants. Completion is expected in 2027.