Esperion Announces Initiation of Three Pivotal Phase 3 Studies for Bempedoic Acid
January 09, 2017 at 02:30 am IST
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Esperion Therapeutics, Inc. announced the initiation of the three remaining global pivotal Phase 3 LDL-C lowering efficacy studies of bempedoic acid in atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia and patients considered 'statin intolerant' with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies. The global Phase 3 clinical development program initiated in January 2016 with a global pivotal 52-week long-term safety study. The company announced the initiation of the three remaining global pivotal LDL-C lowering efficacy studies. The overall Phase 3 program – including the ongoing long-term safety study and the three LDL-C lowering efficacy studies in high CVD risk patients (ASCVD, HeFH and 'statin intolerant') – is designed to enroll over 3,200 high CVD risk patients with hypercholesterolemia on optimized background lipid-modifying therapy, specifically patients with ASCVD and/or HeFH who have LDL-C levels of =100 mg/dL; and patients who are only able to tolerate less than the lowest approved daily starting dose of their statin and considered 'statin intolerant' who have LDL-C levels of =100 mg/dL. Global regulatory submissions for an LDL-C lowering indication are expected by the first half of 2019 for a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). Top-line results from the global Phase 3 program in its entirety are expected by mid-2018. Global Pivotal Phase 3 Study 1 (1950 ASCVD and/or HeFH patients): 52-week global pivotal Phase 3 randomized, double-blind, placebo-controlled study evaluating the long-term safety of 180 mg of bempedoic acid versus placebo – initiated in January 2016 – is expected to enroll approximately 1,950 patients with hypercholesterolemia (with ASCVD and/or HeFH) at high CVD risk and whose LDL-C is not adequately controlled with current lipid-modifying therapies. Additional safety data will be obtained from an open-label extension study initiating later this month. Global Pivotal Phase 3 Study 2 (750 ASCVD and/or HeFH patients): 52-week global pivotal Phase 3 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of 180 mg of bempedoic acid versus placebo. This study is expected to enroll 750 patients with hypercholesterolemia (with ASCVD and/or HeFH) at high CVD risk and whose LDL-C is not adequately controlled with current lipid-modifying therapies. The study will be conducted at approximately 125 sites in the U.S., Canada and Europe. The primary objective is to assess the 12-week LDL-C lowering efficacy of patients treated with bempedoic acid versus placebo. Secondary objectives include evaluating the 24-week LDL-C lowering efficacy, and 52-week safety and tolerability of bempedoic acid 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. Global Pivotal Phase 3 Study 3 (300 patients considered 'statin intolerant'): 24-week global pivotal Phase 3 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of 180 mg of bempedoic acid versus placebo. This study is expected to enroll 300 patients with hypercholesterolemia on optimized background lipid-modifying therapy, including patients considered 'statin intolerant'. The study will be conducted at approximately 70 sites in the U.S. and Canada. The primary objective is to assess the 12-week LDL-C lowering efficacy of patients treated with bempedoic acid versus placebo. Secondary objectives include evaluating the 24-week LDL-C lowering efficacy, safety and tolerability of bempedoic acid versus placebo and effects on other risk markers, including non-HDL-C, total cholesterol, apoB and hsCRP. Global Pivotal Phase 3 Study 4 (225 patients considered 'statin intolerant'): 12-week global pivotal Phase 3 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of 180 mg of bempedoic acid versus placebo as an add-on to 10 mg of ezetimibe. This study is expected to enroll 225 patients with hypercholesterolemia on optimized background lipid-modifying therapy, including ezetimibe, and patients considered 'statin intolerant'. The study will be conducted at approximately 75 sites in the U.S., Canada and Europe. The primary objective is to assess the 12-week LDL-C lowering efficacy of patients treated with bempedoic acid versus placebo when added to ezetimibe. Secondary objectives include evaluating safety and tolerability of bempedoic acid when added to ezetimibe, and effects on other risk markers, including non-HDL-C, total cholesterol, apoB and hsCRP.
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.