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Esperion Announces Publication in the Journal of the American Medical Association of Bempedoic Acid Phase 3 Study 2 Results
– Study 2 Demonstrated that Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP – – Over 52-Weeks, Overall Adverse Events in the Bempedoic
About this update from Esperion Therapeutics, Inc.
[{"type":"text","content":" – Study 2 Demonstrated that Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP – – Over 52-Weeks, Overall Adverse Events in the Bempedoic Acid Treatment Arm were Comparable to Placebo – – Bempedoic Acid is being developed as an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol – – Research by Anne C. Goldberg, MD, FACP, FAHA, FNLA published in the Journal of the American Medical Association –\n ANN ARBOR, Mich., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) is pleased to announce that the results from the 779 patient, 52 week, Phase 3, double-blind, randomized placebo-controlled study of bempedoic acid (Study 2, also known as CLEAR Wisdom) were published today in the Journal of the American Medical Association (JAMA). Bempedoic acid is being developed as a, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination (FDC) tablets’ new drug applications (NDAs) are currently under regulatory review by the U.S. Food and Drug Administration (FDA), and the marketing authorisation applications (MAAs) are currently under centralized review by the European Medicines Agency (EMA). Study 2 evaluated the long-term safety, tolerability and efficacy, of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) inadequately controlled with current lipid-modifying therapies, added-on to maximally tolerated statin therapy, which may mean no statin at all. The JAMA publication includes results from the primary efficacy endpoint of LDL-C lowering at 12-weeks and key secondary endpoints of safety and tolerability over 52-weeks, including that bempedoic acid: significantly lowered LDL-cholesterol by 17 percent on background maximally tolerated statin therapy at 12 weeks, and the effect was durable through 52-weeks;significantly lowered high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 19 percent, and the effect was durable through 52-weeks;reduced hemoglobin A1c (HbA1c) by 0.21% vs. placebo in patients with...