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Esperion Therapeutics Announces Initiation of Phase 2 Clinical Study of Bempedoic Acid in Patients Treated With High-Dose Statin Therapy


Esperion Therapeutics, Inc. (NASDAQ: ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, today announced initiation of its Phase 2 pharmacokinetics/pharmacodynamics (PK/PD) study (ETC-1002-035) of bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin. The Company expects to announce top-line results from the study by mid-year.

"Bempedoic acid has significant potential to be a new therapeutic option, not only for patients who are unable to tolerate statin therapy, but also as an ‘add-on' for those patients already taking a statin who need additional LDL-C lowering," said Tim M. Mayleben, president and chief executive officer of Esperion. "We expect completion of this study will demonstrate incremental efficacy when added to a high-dose statin, which is important to extend the clinical profile of bempedoic acid and market potential in patients who are not adequately treated with maximum statin therapy."

ETC-1002-035 is a Phase 2 randomized, double-blind, parallel group study evaluating 60 patients on stable atorvastatin 80 mg per day. All patients in the study will receive 80 mg of atorvastatin for four weeks. Patients will then be randomized to receive either 180 mg of bempedoic acid, or placebo, for four weeks. The study will enroll patients at approximately 20 centers across the U.S. The primary objectives of the study are to assess the LDL-C lowering efficacy of bempedoic acid versus placebo on a background of atorvastatin 80 mg, as well as multiple-dose plasma PK of atorvastatin 80 mg alone and in combination with bempedoic acid. Secondary objectives include assessing the effect of bempedoic acid on lipid and cardiometabolic biomarkers, including high-sensitivity C-reactive protein; characterizing the tolerability and safety of bempedoic acid; and evaluating the steady-state plasma PK of bempedoic acid.

Next month, the Company also intends to initiate a Phase 1 clinical pharmacology study of bempedoic acid (ETC-1002-037), which will be an open label, drug-drug interaction study to assess the safety and tolerability of bempedoic acid at steady-state, as well as the PK of single doses of the highest-doses of the most commonly prescribed statins: atorvastatin 80 mg, rosuvastatin 40 mg, simvastatin 40 mg, and pravastatin 80 mg. The Company expects to announce top-line results from the study by mid-year.

Esperion's Commitment to Cardiometabolic Disease

Esperion is committed to improving the lives of patients with hypercholesterolemia by developing therapies to lower LDL-C. Esperion scientists discovered bempedoic acid and the LDL-C lowering therapy is in late stage development. Esperion plans to develop both bempedoic acid and a fixed dose combination of bempedoic acid and ezetimibe with a particular focus on patients with hypercholesterolemia who are considered intolerant of statin therapy. It is estimated that approximately 10% of patients who are prescribed statins, 3.5 million patients in the U.S., are considered statin intolerant.

Posted-In: News FDA Press Releases


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