Esperion Announces Three Data Presentations of the NEXLETOL (bempedoic acid) Tablet and the NEXLIZET (bempedoic acid and ezetimibe) Tablet at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology (A

ANN ARBOR, Mich., March 28, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that two pooled analyses from four Phase 3 clinical trials of NEXLETOL and results from the Phase 2 (1002-058) study of NEXLIZET were presented at the American College of Cardiology’s 69^th Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).

A poster titled “Bempedoic Acid 180 mg + Ezetimibe 10 mg Fixed Combination Drug Product vs Ezetimibe Alone or Placebo in Patients with Type 2 Diabetes and Hypercholesterolemia” was presented by Harold E Bays, MD, FOMA, FTOS, FACC, FACE, FNLA. The poster highlighted that in the Phase 2 (1002-058) study, NEXLIZET significantly lowered LDL-Cholesterol (LDL-C) by a mean 40% compared to placebo, reduced high-sensitivity C-reactive protein (hsCRP) by 25% compared to baseline and resulted in no worsening of glycemic control. The incidence of adverse events rates were generally comparable to placebo.

In addition, a poster, titled “Factors Influencing Bempedoic Acid–Mediated Reductions in High-sensitivity C-reactive Protein: Analysis of Pooled Patient-level Data from 4 Phase 3 Clinical Trials” was presented by Eric S. G. Stroes, MD, PhD. The poster highlighted that in the pooled Phase 3 studies, NEXLETOL significantly lowered hsCRP in patients with hypercholesterolemia regardless of the presence or intensity of background statin therapy. In patients whose hsCRP levels were >2 mg/L at baseline, the analysis showed NEXLETOL significantly reduced this marker of inflammation by 42% at 12 weeks.

The third poster, titled “Bempedoic Acid Efficacy and Safety in Patients at High Risk for CVD Treated with or Without Ezetimibe: Pooled Analysis of 4 Phase 3 Clinical Trials” was presented by Maciej Banach, MD, PhD, FAHA, FESC. The pooled analysis showed that in the Phase 3 studies, NEXLETOL provided significant additional LDL-C lowering as well as significantly lowered other lipid (total cholesterol, non-HDL-C Apo B, HDL-C) endpoints, regardless of the presence of background ezetimibe. Importantly, the safety profile of NEXLETOL was similar with or without background ezetimibe therapy.

“We are pleased with the final results of the Phase 2 study that highlight NEXLIZET achieved an impressive 40 percent LDL-C lowering, a significant 25 percent reduction in hsCRP and did not worsen glycemic control in patients with Type 2 diabetes. The additional pooled analyses from the Phase 3 LDL-C lowering development program demonstrate NEXLETOL can be safely added to multiple LDL-C medicines, which is important to help more patients reach their LDL-C goals,” said Tim Mayleben, president and chief executive officer of Esperion. “These additional analyses further affirm the efficacy and safety of our medicines for the millions of patients needing to lower their bad cholesterol.”