Initiation of three pivotal phase 3 studies for bempedoic acid announced
Esperion Therapeutics, Inc. announced the initiation of the three remaining global pivotal Phase 3 LDL-C lowering efficacy studies of bempedoic acid in atherosclerotic cardiovascular disease (ASCVD), heterozygous familial hypercholesterolemia (HeFH) and patients considered "statin intolerant" with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies.
The global Phase 3 clinical development program initiated in January 2016 with a global pivotal 52-week long-term safety study.
The overall Phase 3 program — including the ongoing long-term safety study and the three LDL-C lowering efficacy studies in high CVD risk patients (ASCVD, HeFH and "statin intolerant") — is designed to enroll over 3,200 high CVD risk patients with hypercholesterolemia on optimized background lipid-modifying therapy, specifically patients with ASCVD and/or HeFH who have LDL-C levels of ≥100 mg/dL; and patients who are only able to tolerate less than the lowest approved daily starting dose of their statin and considered "statin intolerant" who have LDL-C levels of ≥100 mg/dL. Global regulatory submissions for an LDL-C lowering indication are expected by the first half of 2019 for a New Drug Application to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA).
Top-line results from the global Phase 3 program in its entirety are expected by mid-2018.