Esperion says bempedoic study meets primary endpoint
Esperion Therapeutics announced that top-line results from its Phase 2 pharmacokinetics and pharmacodynamics study of bempedoic acid added to atorvastatin 80 mg, or 1002-035, demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22% with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported."With the positive clinical results of bempedoic acid added to high-dose statins, and following engagement with global regulatory agencies, we are pleased to include in our ongoing global Phase 3 program patients with elevated LDL-C levels inadequately treated with current lipid-modifying therapies, including patients on any statin at any dose. Bempedoic acid has demonstrated consistent LDL-C lowering efficacy, safety, and tolerability in completed Phase 1 and Phase 2 studies, including most recently in combination with high-dose statins. We believe that bempedoic acid is well-positioned as a once-daily, oral therapy for patients with hypercholesterolemia taking maximally tolerated statin therapy and/or ezetimibe who require additional LDL-C lowering, including patients considered 'statin intolerant'. We remain keenly focused on initiating both the bempedoic acid global Phase 3 efficacy program and our cardiovascular outcomes study before year-end," said Esperion CEO Tim Mayleben.