Esperion announces positive top-line results from Phase 3 Bempedoic Acid study
Esperion announced positive top-line results from its global, pivotal Phase 3 clinical study. This trial 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 patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia. These results complete our global pivotal phase 3 LDL-C lowering development program of bempedoic acid. The study included 779 high cardiovascular risk patients taking maximally tolerated statins who required additional LDL-C lowering. The study achieved its efficacy endpoints and other key measures at 12 weeks, including: On-treatment LDL-C lowering of an additional 18%, and in the intent to treat analysis, LDL-C lowering of an additional 17%; Reduction of 19% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease; Reduction in hemoglobin A1c of 0.21% vs. placebo in patients with diabetes; Safety and Tolerability of Bempedoic Acid Over 52 Weeks. In this study, bempedoic acid was observed to be safe and well-tolerated. The results showed no clinically relevant differences between the bempedoic acid and placebo treatment groups in the occurrence of adverse events with 70% and 71%, respectively; serious adverse events with 20% and 19%, respectively; discontinuations due to AEs with 11% and 9%, respectively; fatal adverse events with 1.1% and 0.8%, respectively. No fatal adverse events were determined to be related to study medication. CV deaths were balanced between the study arms. The bempedoic acid arm included a case of gas poisoning and a case of sepsis as a complication of planned abdominal surgery. No fatal AEs due to neoplasms. 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.