THOUSAND OAKS, Calif., Dec. 17, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that 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 with evolocumab 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, compared to placebo and ezetimibe were consistent with results observed in the MENDEL Phase 2 study.
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. 1
The MENDEL-2 trial evaluated safety, tolerability and efficacy of evolocumab in 614 patients with high cholesterol (LDL-C ≥ 100 mg/dL and < 190 mg/dL) who were not receiving lipid-lowering therapy. Patients 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).
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."Data from the MENDEL-2 monotherapy study in more than 600 patients provide the first of Phase 3 results from our comprehensive development program for evolocumab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The positive results we have seen with two distinct dosing options suggest that evolocumab may offer a promising approach to treat patients with high cholesterol." Details of the MENDEL-2 study results will be submitted to a future medical conference and for publication.