Amgen Astellas Biopharma Reports Positive Phase 2 Results For AMG 145
Amgen Astellas Biopharma K.K. reported positive results for the Phase II study evaluating evolocumab (AMG 145) for the reduction of low-density lipoprotein cholesterol (LDL-C) in statin-treated Japanese patients. The company presented the positive data at the 78th Annual Scientific Meeting of the Japanese Circulation Society and published it electronically in the online Circulation Journal of the Japanese Circulation Society.
The Phase 2 YUKAWA (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study assessing evolocumab achieved its primary endpoint of the percent reduction from baseline at week 12 in LDL-C. The randomized, double-blind, placebo-controlled study assessed the safety, efficacy, and tolerability of evolocumab in 307 statin-treated Japanese patients who remain at high risk for cardiovascular events.
Professor Atsushi Hirayama of Nihon University Graduate School of Medicine, Department of Cardiovascular Medicine, and lead author of the study said, “These study results showed that evolocumab, the PCSK9 inhibitor with a novel mechanism of action, improves lipid parameters at the same dose level as overseas studies in Japanese patients. We look forward to the results of the Phase 3 study in Japanese patients (YUKAWA-2) and the multinational collaborative study (FOURIER), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease, including Japanese patients.”
Hypercholesterolemia or high cholesterol is the most common form of dyslipidemia, an abnormality of lipids in the blood. Dyslipidemia affects an estimated 300 million patients in the U.S., Japan as well as Western Europe. Over 71 million adults in the U.S. have high LDL-C6, according to the Centers for Disease Control and Prevention. Elevated LDL-C is known as a major risk factor for cardiovascular disease.
Evolocumab (AMG 145) is a fully human monoclonal antibody designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9). The protein targets LDL receptors for degradation and reduces the liver's ability to remove LDL-C from the blood. The drug binds to PCSK9 and inhibits it from adhering to LDL receptors found on the liver surface. When there are no PCSK9, more LDL receptors are found on the surface of the liver to remove LDL-C.
Overseas clinical data of evolocumab is scheduled to be presented at the American College of Cardiology’s 63rd Annual Scientific Session (ACC.14), to be held this month in Washington, D.C., U.S.