Merck's Cholesterol Lowering Drug Hits Primary Goal In Two Pivotal Trials

Merck & Co., Inc. MRK on Monday shared topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for hyperlipidemia on lipid-lowering therapies, including at least a statin.

Hyperlipidemia refers to having high levels of lipids (fats) in the blood, including cholesterol and triglycerides. It’s a condition that can increase the risk of heart disease and other health problems. 

The CORALreef HeFH and CORALreef AddOn trials met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful greater reductions in low-density lipoprotein cholesterol (LDL-C) for:

• Enlicitide compared to placebo (CORALreef HeFH) and other oral non-statin therapies (CORALreef AddOn).
• There were no clinically meaningful differences in incidences of adverse events (AE) and serious adverse events (SAE) in either trial.

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Results from the three Phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress.

Key takeaways from CORALreef HeFH and CORALreef AddOn studies:

• CORALreef HeFH: Statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus placebo in adults with heterozygous familial hypercholesterolemia (HeFH) who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD) and are treated with a statin.
• CORALreef AddOn: Statistically significant and clinically meaningful reductions in LDL-C for enlicitide versus ezetimibe, versus bempedoic acid and versus ezetimibe and bempedoic acid in adults with hyperlipidemia who have a history of or are at risk for ASCVD and are treated with a statin.

The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef Phase 3 clinical development program, which aims to enroll approximately 17,000 patients across several trials, including two large ongoing trials, CORALreef Lipids and CORALreef Outcomes.

Price Action: MRK stock is trading higher by 0.19% to $79.12 at last check Monday.

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