What's Happening?
Merck has announced positive results from its Phase 3 CORALreef AddOn trial, which evaluated the efficacy and safety of enlicitide decanoate, an investigational oral PCSK9 inhibitor. The study compared enlicitide to other oral non-statin therapies, such
as bempedoic acid and ezetimibe, in adults with hypercholesterolemia at risk for atherosclerotic cardiovascular disease (ASCVD). The trial demonstrated that enlicitide significantly reduced low-density lipoprotein cholesterol (LDL-C) levels by 64.6% from baseline when added to background statin therapy, outperforming the comparators. The results were presented at the American College of Cardiology’s Annual Scientific Session and published in the Journal of the American College of Cardiology.
Why It's Important?
The development of enlicitide as an oral PCSK9 inhibitor represents a significant advancement in the treatment of hypercholesterolemia, a major risk factor for ASCVD. Current PCSK9 inhibitors are injectable, and an oral option could improve patient compliance and accessibility. With ASCVD accounting for a large percentage of cardiovascular deaths, enlicitide's ability to significantly lower LDL-C levels could address a critical unmet need in lipid management. This development could potentially lead to a new standard of care for patients who do not achieve target LDL-C levels with existing therapies.
What's Next?
Merck is continuing to evaluate enlicitide in the ongoing CORALreef clinical trial program, which includes a large cardiovascular outcomes trial. The company aims to bring enlicitide to market as the first approved oral PCSK9 inhibitor, pending regulatory approval. The U.S. Food and Drug Administration has already selected enlicitide to receive the Commissioner’s National Priority Voucher, indicating its potential impact on public health.
