Merck has released the results of the first two of the three CORALreef Phase III clinical trials on enlicitide decanoate.
The CORALreef AddOn and CORALreef HeFH trials explored the potential of the company's investigational oral PCSK9 inhibitor for the treatment of hyperlipidaemia, with the therapeutic meeting all the primary and secondary endpoints.
Notably, during the trial period, enlicitide decanoate triggered a clinically meaningful reduction in low-density liporotein (LDL) cholesterol compared with placebo.
The CORALreef AddOn trial also found that the therapeutic outperformed other commercially available oral non-statin therapies, suggesting it may be approved for the treatment of hyperlipidaemia further down the line.
Treatment with enlicitide decanoate also caused no differences in incidences of adverse events and serious adverse events in either trial.
Key takeaways of the trials include:
- Enlicitide decanoate reduced LDL cholsterol levels significantly in adults with hyperlipidaemia who are at risk for atherosclerotic cardiovascular disease (ASCVD) and are treated with a statin
- Enlicitide decanoate reduced LDL cholesterol levels in adults with heterozygous familial hypercholesterolaemia
- The therapeutic outperformed non-statin therapies ezemtimibe, bempedoic acid and their combination
“If approved, enlicitide would be the first marketed oral PCSK9 inhibitor in the US," noted Dr. Dean Y. Li, president, Merck Research Laboratories.
“Enlicitide is a novel macrocyclic peptide that has the potential to deliver antibody-like efficacy and specificity for the validated PCSK9 mechanism in the form of a daily oral pill. We are working with urgency to make this oral therapy available to patients worldwide.”
It is estimated that ASCVD accounts for 85% of cardiovascular deaths worldwide, and depsite available treatment options, deaths caused by cardiovascular issues are highly commonplace.
“LDL-C is a major modifiable risk driver for atherosclerosis and prioritisation of LDL-C management should be a cornerstone of cardiovascular risk prevention,” commented Dr. Christie M. Ballantyne, principal investigator of the CORALreef HeFH study and Professor of Medicine at Baylor College of Medicine.
The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef Phase 3 clinical development programme, which aims to enroll approximately 17,000 patients across several trials, including two large ongoing trials, CORALreef Lipids and CORALreef Outcomes.