Esperion Announces Completion of Phase 3 LDL-C Lowering Development Program of Bempedoic Acid and Positive Cumulative Results
Phase 3 Program Achieved Safety and Tolerability Objectives ? ? Bempedoic Acid Achieved Additional 18% to 31% LDL-C Lowering in Patients on Maximally Tolerated Statins and Provided Additional 19% to 33% hsCRP Reduction ? ? 5-Component MACE Events in the Bempedoic Acid Arm were 4.0% as Compared to 4.6% for Placebo ? ? Reduction in HbA1c of 0.19% to 0.31% in Patients with Diabetes ? ? NDA submissions expected during 1Q 2019 ?
ANN ARBOR, Mich.,? Esperion (NASDAQ: ESPR) today announced completion of the Phase 3 LDL-C Lowering Development Program of bempedoic acid and positive cumulative results. The program consisted of four, pivotal, Phase 3, randomized, double-blind, placebo controlled studies to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid 180 mg compared to placebo in high cardiovascular risk patients including atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) patients. The Phase 3 program included 3,621 high cardiovascular risk patients taking maximally tolerated statin (which could include no statin) who required additional LDL-C lowering. The Program achieved its efficacy endpoints and other key measures at 12 weeks for bempedoic acid, including:- On-treatment LDL-C lowering of an additional 18 percent to 31 percent (vs. placebo, p<0.001), and in the intent to treat analysis, LDL-C lowering of an additional 17 percent to 28 percent (p<0.001).
- Reductions of 19 percent to 33 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease.
- Reductions in hemoglobin A1c (HbA1c) of 0.19% to 0.31% vs. placebo in the subset of 1002 patients with diabetes
- 3-component MACE: 1.9 percent for bempedoic acid compared to 2.3 percent for placebo
- 4-component MACE: 3.8 percent for bempedoic acid compared to 4.2 percent for placebo
- 5-component MACE: 4.0 percent for bempedoic acid compared to 4.6 percent for placebo
- Adverse events (AEs) with 73 percent in each group;
- Serious adverse events (SAEs) with 14 percent and 13 percent, respectively; SAE neoplasms were balanced at 1 percent in both arms.
- Discontinuations due to AEs with 11 percent and 8 percent, respectively;
- Fatal adverse events were very low overall at ?0.8 percent and 0.3 percent, respectively (compared to a 1.8% fatality rate for people 65-74 year olds according to the CDC).? No fatal adverse events were determined to be related to study medication. ? CV deaths were balanced between the study arms (0.4% vs. 0.3%) as was sepsis (0.1% in both arms). ? The bempedoic acid arm included a case of gas poisoning and a case of pancreatitis resulting from a pancreatic pseudocyst.
- Two pivotal studies evaluating bempedoic acid (Studies 1 & 2) in 3,008 patients with ASCVD and/or HeFH on maximally-tolerated statins, with top-line results reported in?May 2018 and October 2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 & 4) in 613 patients with ASCVD, or at a high risk for ASCVD, considered statin intolerant, with top-line results reported in May and?March 2018, respectively;
- One pivotal study evaluating the bempedoic acid / ezetimibe combination pill (053 Study) in 382 patients with ASCVD, or at high risk for ASCVD, on maximally tolerated statins, with top-line results reported in August.