Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

Amgen (NASDAQ: AMGN) today announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52. The mean percent reduction in LDL-C, or "bad" cholesterol, was consistent with the results observed in the 52-week analysis of the Phase 2 OSLER (Open Label Study of Long TERm Evaluation Against LDL-C) 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.

The DESCARTES study evaluated safety, tolerability and efficacy in 901 patients with high LDL-C and a range of cardiovascular risk. Background lipid-lowering therapy was optimized to one of four treatment groups (diet alone; diet plus atorvastatin 10 mg; diet plus atorvastatin 80 mg; and diet plus atorvastatin 80 mg plus ezetimibe 10 mg) for individual patients based on their LDL-C and cardiovascular risk. Patients with a fasting LDL-C ≥ 75 mg/dL were then randomized to receive monthly subcutaneous evolocumab 420 mg or placebo in combination with background lipid-lowering therapy.

Evolocumab significantly reduced LDL-C, as measured by the accepted standard, preparative ultracentrifugation, from baseline at week 52 compared to placebo.  LDL-C reduction at week 12 was consistent with the long-term efficacy at week 52.

Safety was balanced across treatment groups. The most common adverse events (> 5 percent in evolocumab) were nasopharyngitis, upper respiratory tract infection, influenza and back pain.

"Data from the Phase 3 DESCARTES study of evolocumab add to the promising safety and efficacy data we recently saw in the MENDEL-2 study and 52-week Phase 2 OSLER study," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "These data contribute to the growing body of research suggesting that evolocumab may offer a new treatment option for patients with dyslipidemia."

Details of the DESCARTES study results will be submitted to a future medical conference and for publication.

According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C. Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.