Merck says MK-0616 ‘significantly reduced’ LDL-C in Phase 2b study

Merck announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol from baseline to week eight for four doses of MK-0616 versus placebo. At week eight, all doses of MK-0616 "significantly reduced" LDL-C compared to placebo and the placebo-adjusted reduction from baseline ranged from 41.2% to 60.9%, Merck said in a statement. MK-0616 was generally well-tolerated at all four doses studied, the company added. "Despite widely available statin treatments, millions of patients are still not able to lower their cholesterol to the guideline-recommended levels and as a result are at increased risk for serious cardiovascular complications associated with atherosclerosis," said Dr. Christie Ballantyne, principal investigator of the study and Professor of Medicine at Baylor College of Medicine. "Currently available PCSK9 inhibitors are effective tools to treat hypercholesterolemia but must be administered by injection. With these promising data showing that MK-0616 reduced LDL-C levels by up to 60.9%, MK-0616 should be further studied for its potential as a daily oral medicine." "These data reinforce our confidence that MK-0616 could become the first oral PCSK9 inhibitor, with the potential to change the way patients with hypercholesterolemia who need additional LDL-C reduction are treated. This may allow many more patients to reach their LDL-C treatment goals," said Dr. Joerg Koglin, vice president, global clinical development, Merck Research Laboratories. "We look forward to advancing this program into Phase 3 development in the second half of this year."