A new oral formulation of a PCSK9-inhibitor, cholesterol-lowering drug in development by Merck has shown encouraging results in a phase 2 study.
The study was presented by Christie Ballantyne, MD, Baylor College of Medicine, Houston, Texas at the recent American College of Cardiology (ACC) Scientific Session/World Congress of Cardiology (WCC) 2023.
It was also simultaneously published online in the Journal of the American College of Cardiology on March 6.
"In this diverse population of hypercholesterolemic patients, all doses of MK-0616 showed superior reduction of LDL vs placebo up to a 60.9% placebo-adjusted reduction from baseline to week 8, which was consistent across subgroups," Ballantyne reported.
"Reduction in ApoB and non-HDL cholesterol were consistent with that of LDL cholesterol, with up to a 51.8% reduction in ApoB and a 55.8% reduction in non-HDL," he noted.
He added that the drug was well tolerated with no difference in adverse events across the treatment groups compared with placebo.
"These data support the further development of MK-0616, an oral PCSK9 inhibitor that may improve access to effective LDL-cholesterol lowering therapies and improve attainment of guideline-recommended LDL goals aimed at reducing cardiovascular risk," Ballantyne concluded. "The results are encouraging for a phase 3 program that is now being designed."
