Esperion (NASDAQ: ESPR) today announced that pooled analyses from four Phase 3 clinical studies of bempedoic acid were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia. 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).
The presentation, titled "Bempedoic Acid and Glycemic Control: A Pooled Analysis of 4 Phase 3 Clinical Trials" was delivered by Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA Director of the Lipid Clinic at St. Michael's Hospital and Professor of Medicine and Nutritional Sciences, University of Toronto. The presentation highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by 0.19% versus placebo in patients with diabetes (n=1,134) at 12 weeks. The analysis also showed that patients on bempedoic acid had fewer instances of new-onset diabetes as well as hyperglycemia than those on placebo.
In addition, a poster, titled "Efficacy of Bempedoic Acid: A Pooled Analysis of 4 Pivotal Phase 3 Clinical Trials" was presented by Maciej Banach, MD, PhD, FAHA, FESC. The poster highlighted that in the pooled Phase 3 studies, bempedoic acid significantly lowered LDL-C in patients with hypercholesterolemia when added-on to maximally tolerated statin therapy, which may mean no statin at all. In patients on background statin therapy, bempedoic acid lowered LDL-Cholesterol by 18% compared to placebo. In patients not on statin background therapy and considered statin intolerant, bempedoic acid lowered LDL-Cholesterol by 25% compared to placebo.
"We are very pleased with the pooled analyses from the Phase 3 LDL-C lowering clinical development program showing bempedoic acid not only lowered LDL-C by 25% but also reduced HbA1c by 0.19% in 1,134 patients with diabetes," said Tim Mayleben, president and chief executive officer of Esperion. "These pooled analyses further support our confidence that bempedoic acid could be a convenient and important, oral, once-daily drug for the millions of patients on maximally tolerated statin therapy who need additional LDL-C lowering."