PCSK9 antibody meets LDL reduction endpoints in phase 3 trial
The PCSK9 antibody evolocumab (AMG145, Amgen) met its co-primary endpoints in a phase 3 trial, namely the percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12 as compared to placebo and ezetimibe.
The mean percent reductions in LDL-C were consistent with results observed in the MENDEL Phase 2 study, which had shown significantly larger reductions from baseline with AMG145 than with placebo or ezetimibe.
Safety was balanced across treatment groups. The most common (>2 percent in evolocumab combined group) adverse events (AEs) were headache, diarrhea, nausea and urinary tract infection.
The phase 3 MENDEL-2 (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2) trial is a randomised, multi-center, double-blind, double-dummy, stratified, placebo and ezetimibe-controlled study to evaluate the efficacy and safety of the investigational fully human monoclonal antibody against PCSK9. 614 hyperlipidemic patients with a 10-year Framingham risk score of 10 percent or less who were not receiving lipid-lowering therapy were randomized to one of six treatment groups to compare two dosing regimens of evolocumab (140 mg every two weeks or 420 mg monthly) with placebo and ezetimibe (10 mg daily).
MENDEL-2 is part of the AMG145 clinical trial program PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations. MENDEL-2 provides the first phase 3 results of this comprehensive development program. Details of the MENDEL-2 study results will be submitted to a future medical conference and for publication.
Press release Amgen, 17 December 2013