LAPLACE-2 trial of evolocumab plus statins success- Amgen

Amgen has announced that the Phase III LAPLACE-2 (LDL-C Assessment with P CSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the published results observed for the same doses in the Phase II LAPLACE-TIMI 57 (LAPLACE-Thrombolysis In Myocardial Infarction-57) trial for evolocumab compared to placebo; and in the Phase II MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels) study for evolocumab compared to ezetimibe. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.

The study showed that adding evolocumab to statin therapy may help patients control their LDL cholesterol levels when high doses of statins are not sufficient.Details of the Phase III LAPLACE-2 study results will be submitted to a future medical conference and for publication..