Merck PCSK9 Inhibitor Meets Trial Goals

Merck’s investigational oral PCSK9 inhibitor enclicitide decanonate met all its primary and secondary endpoints in the Phase 3 CORALreef Lipids trial evaluating the drug to treat adults with hypercholesterolemia on a moderate or high-intensity statin. A company statement says treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in LDL (low-density lipoprotein) cholesterol compared to placebo at week 24. The company says that discontinuations due to adverse events were low and comparable between treatment groups.

Enlicitide is described as a potentially first oral PCSK9 inhibitor designed to lower LDL cholesterol through the same biological mechanism as currently approved monoclonal antibody, injectable PCSK9 inhibitors, but in a daily pill form. It is said to be a novel small molecule macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.