* AMG145 reduced LDL up to 66 percent in trial
* Largest PCSK9 trial so far
By Deena Beasley and Bill Berkrot
LOS ANGELES, Nov 6 Amgen Inc's
experimental cholesterol-lowering drug, AMG145, reduced levels
of "bad" cholesterol up to 66 percent in patients already taking
statin drugs, according to results from a mid-stage trial that
were presented on Tuesday.
The trial results were in line with two other studies
showing significant reductions in LDL cholesterol that were
unveiled on Monday at the American Heart Association scientific
meeting in Los Angeles.
The latest study of 629 patients is the largest trial so far
of a drug in a new class, known as PCSK9 inhibitors, designed to
target a protein that prevents the body from removing artery
blocking LDL cholesterol from the bloodstream.
The Phase 2 trial showed a mean reduction in LDL versus a
placebo of 42 percent for patients injected with 70 mg of AMG145
every two weeks, 60 percent in the 105 mg group and 66 percent
in the 140 mg group.
When the drug was administered every two weeks, the mean
reduction in LDL was 42 percent for the 280 mg group, 50 percent
for the 350 mg group and 50 percent in the 420 mg group.
"We had some patients with entry LDLs as low as 85," said
Dr. Robert Giugliano, associate professor at Brigham and Women's
Hospital in Boston, and the study's lead investigator, "At the
end, some had LDLs measured in the teens."
Current guidelines from the American Heart Association call
for LDL levels to be 100, but some cardiologists believe even
lower levels would be beneficial.
The most common side effects seen in the trial were
cold-like symptoms, cough and nausea.
The results were presented at the AHA meeting and published
in the Lancet medical journal.
(Editing by Ken Wills)