Amgen LAPLACE-2 Trial of Evolocumab (AMG 145) Meets Co-Primary Endpoints Of LDL Cholesterol Reduction
Amgen this week reported positive top-line results from the Phase III LAPLACE-2 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) trial assessing evolocumab in combination with statins in high cholesterol patients.
Executive Vice President of Research and Development, Sean E. Harper, said, "As statins continue to be an important treatment option in patients with high cholesterol, we are very encouraged by the Phase 3 data from the LAPLACE-2 study. Adding evolocumab to statin therapy may help patients control their LDL cholesterol levels when high doses of statins are not sufficient."
1,896 patients with high cholesterol took part in the LAPLACE-2 trial. Evolocumab with statin therapy was measured against placebo and ezetimibe and assessed for safety, efficacy, and tolerability. Patients in the trial were randomized to one of 24 treatment groups in order to study effects of subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) against ezetimibe (10 mg daily) and subcutaneous placebo (every two weeks or monthly) or when added to various daily dosage of statin therapies.
Mean percent reductions in low-density lipoprotein cholesterol (LDL-C) proved consistent with published Phase 2 LAPLACE-TIMI 57 (LAPLACE-Thrombolysis In Myocardial Infarction-57) results for same evolocumab doses against placebo. Percent reduction endpoints from baseline in LDL-C, also known as ‘bad’ cholesterol, were attained at week 13 and the mean percent reduction at weeks 10 and 12. Additionally, co-primary endpoints were also met in the Phase 2 MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels) study for evolocumab against ezetimibe.
Amgen is developing evolocumab as an investigational human monoclonal antibody to inhibit protein PCSK9 (proprotein convertase subtilisin/kexin type 9) which diminishes the liver’s ability to take away LDL-C from the blood. Over 70 million adults in the US today have high levels of LDL-C according to the Centers for Disease Control and Prevention.
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