Final Phase III study of bempedoic acid to treat atherosclerotic cardiovascular disease .- Esperion
Esperion announced positive top-line results from its global, pivotal Phase III clinical study (Study 2 or 1002-047) . 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 (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH). These results complete the global pivotal phase III 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 percent (vs. placebo, p<0.001), and in the intent to treat analysis, ldl-c lowering of an additional 17 percent (p><0.001). reduction of 19 percent in high-sensitivity c-reactive protein (hscrp), an important marker of the underlying inflammation associated with cardiovascular disease. reduction in hemoglobin a1c (hba1c) of 0.21% vs. placebo in patients with diabetes.>0.001).>0.001),>
Safety and Tolerability of Bempedoic Acid Over 52 Weeks. In this 52-week study, adjudicated major adverse cardiovascular events (MACE) in the bempedoic acid arm as compared to placebo were: 3-component MACE: 2.7 percent for bempedoic acid compared to 4.7 percent for placebo. 4-component MACE: 5.7 percent for bempedoic acid compared to 7.8 percent for placebo. 5-component MACE: 6.1 percent for bempedoic acid compared to 8.2 percent for placebo. 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 (AEs) with 70 percent and 71 percent, respectively; Serious adverse events (SAEs) with 20 percent and 19 percent, respectively; Discontinuations due to AEs with 11 percent and 9 percent, respectively; Fatal adverse events with 1.1 percent and 0.8 percent, respectively. No fatal adverse events were determined to be related to study medication. CV deaths were balanced between the study arms (0.8% vs. 0.8%). 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.
"This is the final clinical study from our global, pivotal Phase III LDL-C lowering program for bempedoic acid. We are now one step closer to being able to provide convenient, cost-effective and complementary LDL-C lowering therapies for use by patients who require additional LDL-C lowering,� said Tim M. Mayleben, president and chief executive officer of Esperion.
Comment; Esperion plans to submit New Drug Applications (NDAs) to the FDA 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 (MAAs) to the European Medicines Agency (EMA) during the second quarter of 2019.
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