Merck Starts Phase 3 Clinical Program for Oral PCSK9 Inhibitor

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the company’s Phase 3 clinical program, CORALreef, for MK-0616, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, being evaluated for the treatment of adults with hypercholesterolemia. This is the first Phase 3 clinical program for an oral PCSK9 inhibitor. The first participants are now enrolling in two registrational Phase 3 studies evaluating low-density lipoprotein (LDL) cholesterol reduction: CORALreef Lipids and CORALreef HeFH. Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023.

PCSK9 is a validated target for lowering LDL cholesterol. However, there are no oral PCSK9 inhibitors available to physicians and patients. The Phase 3 CORALreef program follows robust Phase 2b results presented at ACC.23/WCC, in which MK-0616 significantly reduced LDL cholesterol compared to placebo at all doses studied in participants with hypercholesterolemia with a broad spectrum of atherosclerotic cardiovascular disease (ASCVD) risk, including participants on high-intensity statin therapy. MK-0616 was generally well-tolerated.

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