Cholesterol-lowering statins are a lifesaving therapy for many. But even at high doses, statins don’t always produce ideally low levels of harmful LDL cholesterol.
Researchers in the TIMI Study Group at Harvard Medical School, led by Dr. Marc S. Sabatine, are testing a novel drug that may help patients reach their LDL goal safely. AMG 145 works differently than statins by binding to a protein called PCSK9, which assists in the turnover of LDL cholesterol receptors that help clear LDL from the blood. AMG 145 allows more of these receptors to circulate and remove LDL from the bloodstream. “Because AMG 145 is complementary to statins, using both should lead to greater benefit,” says Dr. Sabatine.
The phase 2 study of AMG 145, called LAPLACE-TIMI 57, has been completed and results should be available soon.
In early studies of both AMG 145 and a different PCSK9 inhibitor, LDL dropped by 50% or more. “With PCSK9 inhibitors, we appear to have a therapy that would permit most people to achieve an LDL level of less than 70 milligrams per deciliter (mg/dL), the current recommendation for people with coronary artery disease,” says Dr. Robert P. Giugliano, principal investigator of LAPLACE-TIMI 57, the largest study of its kind to date with this class of drugs.