Esperion Announces Positive Top-Line Results from Final Pivotal Phase 3 Study of Bempedoic Acid
? Study Met Safety and Tolerability Endpoints in 52-Week Study ? ? Bempedoic Acid Achieved Additional 18% LDL-C Lowering in Patients on Maximally Tolerated Statins and Provided Additional 19% hsCRP Reduction ? ? 5-Component MACE Events in the Bempedoic Acid Arm were 6.1% as Compared to 8.2% for Placebo ? ? Reduction in HbA1c of 0.21% in Patients with Diabetes ? ? Conference Call and Webcast on Monday, October 29 at 8:00 a.m. Eastern Time ?
ANN ARBOR, Mich.,-- Esperion (NASDAQ: ESPR) today announced positive top-line results from its global, pivotal Phase 3 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 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 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
- 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
- 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.
- Two pivotal studies evaluating bempedoic acid (Studies 1 & 2) in 3,008 patients with ASCVD on maximally-tolerated statins, with top-line results reported in?May 2018 and in?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.