Esperion today announced that the results from Study 2 (1002-047, also known as CLEAR Wisdom, a pivotal Phase 3 study) of bempedoic acid will be presented in a late-breaking clinical trial session at the American College of Cardiology (ACC) Scientific Sessions & Expo in New Orleans on Monday, March 18th 2019. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet are being developed as complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies. Bempedoic acid and the bempedoic acid / ezetimibe combination tablet new drug applications have been submitted to the United States Food and Drug Administration, as well as are under regulatory review for marketing authorization by the European Medicines Agency.
Study 2 was a 52-week, randomized, double-blind, placebo-controlled study to evaluate the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg compared to placebo in 779 patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). Topline results were previously announced in October 2018.
Details on the presentations are as follows: