Amgen’s drug lowers cholesterol in phase 2

Hannah Blake

pharmaphorum

Amgen has announced that its experimental drug AMG145 reduced levels of “bad” cholesterol by up to 56% in combination with statin drugs in patients with heterozygous familial hypercholesterolemia (HeFH) in phase 2 clinical trials.

AMG145 is part of a promising class of biotech medicines designed to target the protein, PCSK9, which prevents the liver’s ability to remove artery blocking LDLcholesterol (LDL-C) from the bloodstream.

In the trials, which were called RUTHERFORD, AMG145 was found to be statistically significant in decreasing LDL-C versus placebo in HeFH patients on lipid-lowering therapy (statins with or without ezetimibe) when administered by injection every four weeks.

"Despite existing therapies and maintaining a healthy lifestyle, patients with heterozygous familial hypercholesterolemia are prematurely at risk for serious cardiovascular disease due to the difficulty in reducing their LDL-C levels. Data from the RUTHERFORD study suggests that using AMG 145 as an add-on therapy to statins helped these high-risk patients achieve LDL-C goals and offers promise for the treatment of HeFH."

Frederick Raal, M.D., Ph.D., Carbohydrate &amp, Lipid Metabolism Research Unit, Division of Endocrinology &amp, Metabolism, Department of Medicine, University of the Witwatersrand, Johannesburg.

HeFH affects at least one in every 500 people worldwide, making it one of the most common genetic disorders. HeFH causes severe elevations in total cholesterol and LDL-C, which can lead to the premature development of cardiovascular disease.

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