Esperion announces presentation of final Study 3 results of Bempedoic Acid
Esperion announced that the final Phase 3 results from Study 3 were presented at the American Heart Association Scientific Sessions in Chicago. This study evaluated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease, or at high risk for ASCVD with hypercholesterolemia, inadequately treated with maximally tolerated background LDL-C lowering therapy who are only able to tolerate less than the approved daily starting dose of a statin and considered statin intolerant. Topline results were previously announced in May 2018. The 24-week, global pivotal Phase 3 randomized, double-blind, placebo-controlled, multicenter study evaluated the LDL-C lowering efficacy and safety of bempedoic acid 180 mg/day versus placebo added to background lipid-modifying therapy in patients with hypercholesterolemia who are considered statin intolerant. The study was conducted at 67 sites in the U.S. and Canada. A total of 345 patients were randomized 2:1 to receive bempedoic acid or placebo. The primary efficacy objective was to assess the 12-week LDL-C lowering efficacy of bempedoic acid versus placebo. Secondary objectives included evaluating the 24-week LDL-C lowering efficacy of bempedoic acid versus placebo, the safety and tolerability of bempedoic acid versus placebo, and its effects on other risk markers after 12 weeks of treatment, including hsCRP. Esperion plans to submit New Drug Applications to the U.S. Food and Drug Administration for bempedoic acid and the bempedoic acid/ezetimibe combination pill for LDL-C lowering indications during the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency during the second quarter of 2019.