Merck (MSD) announced positive 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 being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin.
The CORALreef HeFH and CORALreef AddOn trials successfully 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 and compared to other oral non-statin therapies. There were no clinically meaningful differences in incidences of adverse events and serious adverse events in either trial.
Merck did not disclose the detailed results of the trials, but said that results from the three phase 3 trials in the CORALreef clinical development program will be presented at a future scientific congress.
Enlicitide is potentially the first oral PCSK9 inhibitor designed to lower LDL-C via the same biological mechanism as currently approved monoclonal antibody injectable PCSK9 inhibitors, but in a daily pill form. Enlicitide is a novel oral macrocyclic peptide that binds to PCSK9 and inhibits the interaction of PCSK9 with LDL receptors.
Hyperlipidemia — high cholesterol — is a disorder characterized by an excess of lipids or fats in the blood, affecting approximately 86 million adults (aged 20 and older) in the U.S. Despite adjusting diet or other lifestyle factors, some individuals can’t reach recommended lipid levels and require medication to treat and manage hyperlipidemia.