Investigational Monoclonal Antibody Significantly Reduces LDL
Amgen announced that treatment with AMG 145 resulted in significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 59% in an efficacy analysis of pooled data from four 12-week Phase 2 studies.
AMG 145 is an investigational human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.
Data from four placebo-controlled, randomized trials of AMG 145 in various patient populations with hyperlipidemia was used to conduct the pre-specified, pooled analyses. The treatment duration was 12 weeks and the primary endpoint was percentage change in LDL-C from baseline in all four trials.
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 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy for Easing Lipid 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 100mg/dL and <190mg/dL) who were not receiving statin therapy.
- LAPLACE-TIMI 57 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined With Statin ThErapy – Thrombolysis In Myocardial Infarction-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 >85mg/dL) when added to a stable dose of statin, with or without ezetimibe.
- RUTHERFORD (RedUction of LDL-C With PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study) evaluated AMG 145 administered subcutaneously every month, in heterozygous familial hypercholesterolemic patients with an LDL-C >100mg/dL who were on a stable dose of statin, with or without ezetimibe.
- GAUSS (Goal Achievement After Utilizing an anti-PCSK9 Antibody in Statin Intolerant Subjects) 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.
Results from the efficacy analysis showed mean reductions in LDL-C from baseline to Week 12, ranging from 40–59% across AMG 145 doses in comparison to 0.1–0.5% for placebo (P=0.001).
AMG 145 treatment was also associated with improvements in other lipid parameters, including high-density lipoprotein cholesterol (HDL-C), triglycerides, apolipoprotein B, lipoprotein(a) and apolipoprotein A1, within each targeted dose frequency of AMG 145.T
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