Merck’s Oral PCSK9 Inhibitor Enlicitide Significantly Reduces LDL Cholesterol in Phase 3 Trials

Merck announced positive topline results from two Phase 3 clinical trials (CORALreef HeFH and CORALreef AddOn) for its investigational oral PCSK9 inhibitor, enlicitide decanoate5.

Enlicitide achieved statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and to existing oral non-statin therapies (ezetimibe, bempedoic acid)125.

The CORALreef HeFH trial focused on adults with heterozygous familial hypercholesterolemia (HeFH), and the CORALreef AddOn study included adults with hyperlipidemia at risk of atherosclerotic cardiovascular disease; all participants were already on statins35.

Enlicitide met all primary and key secondary endpoints in both trials, showing robust efficacy in patients with a high cardiovascular risk profile3.

If approved, enlicitide would become the first oral PCSK9 inhibitor on the U.S. market, offering a daily pill alternative to existing injectable therapies, and potentially expanding the multi-billion dollar PCSK9 inhibitor market345.

Shares of Merck rose following the announcement, and company leadership expressed urgency in bringing this oral therapy to patients worldwide5.

Sources:

1. https://www.bioworld.com/articles/720982-in-two-phase-iiis-mercks-pcsk9-inhibitor-cuts-cholesterol

2. https://www.pharmexec.com/view/phase-iii-trials-show-merck-oral-pcsk9-inhibitor-significantly-reduces-ldl-cholesterol-hyperlipidemia

3. https://www.biospace.com/drug-development/merck-moves-forward-in-bid-to-bring-first-oral-pcsk9-inhibitor-to-market

4. https://www.biopharmadive.com/news/merck-pcsk9-pill-enlicitide-coralreef-study-results/750134/

5. https://ng.investing.com/news/stock-market-news/merck-stock-rises-on-successful-phase-3-trial-results-for-its-cholesterol-drug-93CH-1958496