Merck, Sharp & Dohme (MSD; NYSE: MRK) has commenced Phase III development for its experimental proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, MK-0616, focusing on low-density lipoprotein (LDL) cholesterol reduction in adults with and without heterozygous familial hypercholesterolemia (HeFH). This marks a significant milestone as MK-0616 becomes the first oral drug in its class to reach late-stage trials.
Phase II Success and Tolerability
The investigational molecule has already demonstrated success in a placebo-controlled Phase II study, where it significantly reduced LDL cholesterol levels and was well-tolerated. These positive results have paved the way for the advancement to Phase III trials, indicating the potential efficacy and safety profile of MK-0616.
Plans for Cardiovascular Outcomes Study
In addition to the LDL cholesterol reduction trial, MSD plans to advance MK-0616 to a Phase III cardiovascular outcomes study later this year. This study will measure the time to the first occurrence of a cardiovascular event, including ischemic stroke, myocardial infarction, or urgent arterial revascularization. The outcomes of this study will provide crucial data on the drug’s impact on cardiovascular health, further evaluating its potential as a treatment option for patients at risk of cardiovascular events.-Fineline Info & Tech
