Amgen Inc's experimental drug AMG145 reduced levels of bad cholesterol
by as much as 55 percent in combination with statin drugs in patients
genetically predisposed to high cholesterol, according to data from a midstage
trial presented on Monday.
The new drug, given by injection every four weeks, is part of a
promising new class of biotech medicines known as PCSK9 inhibitors designed to
target a protein that prevents the body from removing artery blocking LDL
cholesterol from the bloodstream.
The Phase II trial found that after 12 weeks, patients treated with a
low dose of AMG145 had a 43 percent reduction in LDL, while those given a
higher dose had a drop of 55 percent. Patients treated with a placebo saw a 1
percent increase in LDL cholesterol. The trial, presented here at the annual
scientific meeting of the American Heart Association, included 168 patients
with heterozygous familial hypercholesterolemia, in which a defective gene
inherited from one parent impairs the ability to properly metabolize LDL. The
disorder is estimated to affect about one in 500 people and causes extremely
high cholesterol.
The most common side effects seen in the trial were injection-site
reactions, cold-like symptoms and headache. AMG145, along with other PCSK9
inhibitors being developed by companies like Pfizer, Regeneron Pharmaceuticals
Inc in partnership with Sanofi and Roche, is a man-made antibody.
Source: Chicago Tribune
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