About the Pooled AnalysesThe pre-specified, pooled analyses of data were from four Phase 2, placebo-controlled, randomized trials of AMG 145 in various patient populations with hyperlipidemia. In each trial, treatment duration was 12 weeks and the primary endpoint was percentage change in LDL-C from baseline, as measured by ultracentrifugation. Patients enrolled in the trials received various doses of AMG 145 subcutaneously every two weeks or monthly. Three of the four trials permitted stable background statin therapy. The trials included:
– MENDEL (
onoclonal Antibody Against PCSK9 to Reduce
levated LDL-C in Patients Currently
rug Therapy for
ipid Levels) evaluated the efficacy, safety and tolerability of AMG 145 administered subcutaneously every two weeks and every four weeks in hyperlipidemic patients (LDL-C ³ 100 mg/dL and < 190 mg/dL) who were not receiving statin therapy.
– LAPLACE-TIMI 57 (
ombined With Statin Th
nfarction-57) evaluated the efficacy, safety and tolerability of AMG 145 administered subcutaneously every two weeks and every four weeks in hyperlipidemic patients at risk for CV disease (LDL-C
85 mg/dL) when added to a stable dose of statin, with or without ezetimibe.
– RUTHERFORD (
ction of LDL-C With PCSK9 Inhibi
isorder Study) evaluated AMG 145 administered subcutaneously every month, in heterozygous familial hypercholesterolemic patients with an LDL-C >100 mg/dL who were on a stable dose of statin, with or without ezetimibe.
– GAUSS (
tilizing an anti-PCSK9 Antibody in
ubjects) evaluated the efficacy, safety and tolerability of AMG 145 dosed subcutaneously every month, in hyperlipidemic patients who could not tolerate effective statin doses due to muscle-related side effects.
About AMG 145
AMG 145 is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
AMG 145, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
About the AMG 145 Clinical Trial Program
PROFICIO, which stands for the
educe LDL-C and Cardiovascular
nhibition of P
n Different P
pulations, is the large and comprehensive clinical trial program evaluating AMG 145.
The Phase 3 clinical trial program for AMG 145 builds upon the successful Phase 2 studies and includes 12 trials, with a combined planned enrollment of more than 27,000 patients. The Phase 3 studies will evaluate AMG 145 administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2), in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2), as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2), and in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia.
Five studies of AMG 145 will provide long-term safety and efficacy data, including the FOURIER (
esearch with PCSK9
nhibition in Subjects with
isk) study, which will assess whether treatment with AMG 145 compared to placebo reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease.
Additional information about clinical trials of AMG 145 can be found at
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