Esperion Therapeutics, Inc. Completes Enrollment of Pivotal Phase 3 Long-Term Safety and Tolerability Study of Bempedoic Acid in Patients with Hypercholesterolemia
January 25, 2017 at 01:05 pm
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Esperion Therapeutics, Inc. announced completion of patient enrollment in the global pivotal Phase 3 long-term safety and tolerability study of bempedoic acid. Enrollment of this study was completed ahead of schedule in approximately 2,000 patients treated with bempedoic acid or placebo at high cardiovascular disease (CVD) risk with hypercholesterolemia whose LDL-C is not adequately controlled with current lipid-modifying therapies. Top-line results from this study are expected by second quarter 2018. The 52-week global pivotal Phase 3 randomized, double-blind, placebo-controlled study is evaluating the long-term safety and tolerability of 180 mg of bempedoic acid versus placebo in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) at high CVD risk whose LDL-C is not adequately controlled with current lipid-modifying therapies. The study enrolled patients at approximately 100 sites in the U.S., Canada and Europe. The primary objective is to assess the safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the LDL-C lowering efficacy of bempedoic acid on top of maximally tolerated statin and other lipid altering therapies at 12, 24 and 52 weeks versus placebo. Effects on other risk markers, including non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, apolipoprotein B (apoB) and high sensitivity C-reactive protein (hsCRP), will also be evaluated.
Esperion Therapeutics, Inc. is a pharmaceutical company. The Company is focused on developing and commercializing oral, once-daily, non-statin medicines for patients struggling with elevated low-density lipoprotein cholesterol (LDL-C). The Company's products include NEXLETOL, NEXLIZET, NILEMDO and NUSTENDI. The Company's NEXLETOL and NEXLIZET (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD). Its NEXLETOL is an ATP Citrate Lyase (ACL), inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. Its NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine. Its Pipeline product include Next Generation ACLYi.
Esperion Therapeutics, Inc. Completes Enrollment of Pivotal Phase 3 Long-Term Safety and Tolerability Study of Bempedoic Acid in Patients with Hypercholesterolemia