Esperion’s cholesterol drug bempedoic acid has succeeded in a phase 3 trial by achieving its efficacy endpoints and other key measures in patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
The 52-week, randomized, double-blind, placebo-controlled study investigated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180mg in comparison to placebo.
It was carried out in 779 high cardiovascular risk patients taking maximally tolerated statins who required further lowering of their LDL-C levels.
Esperion said that, on-treatment, its investigational cholesterol drug could lower LDL-C by an additional 18% compared to placebo. In the intent to treat analysis, bempedoic acid could bring down the levels of LDL-C by an additional 17%.
According to the US-based lipid management company, the reduction of 19% in high-sensitivity C-reactive protein (hsCRP) is a major marker of the underlying inflammation related to cardiovascular disease.
Esperion’s cholesterol drug was shown to have resulted in a reduction of 0.21% in hemoglobin A1c (HbA1c) in comparison to placebo in patients with diabetes.
The 5-component adjudicated major adverse cardiovascular events (MACE) of bempedoic acid were 6.1% against the 8.2% recorded by placebo.
The primary efficacy goal of the phase 3 trial was to evaluate the 12-week LDL-C lowering efficacy of bempedoic acid in comparison to placebo. Secondary objectives of the phase 3 trial were assessment of the safety and tolerability of Esperion’s cholesterol drug compared to placebo, the 24-week and 52-week LDL-C lowering efficacy of the investigational drug versus placebo, and its effects on other risk markers following 12 weeks of treatment, including hsCRP.
The global phase 3 LDL-C lowering development program found bempedoic acid to be safe and well-tolerated, said the US pharma company.
Esperion president and CEO Tim Mayleben said: “This is the final clinical study from our global, pivotal Phase 3 LDL-C lowering program for bempedoic acid. We are now one step closer to being able to provide convenient, cost-effective and complementary LDL-C lowering therapies for use by patients who require additional LDL-C lowering.
“We express our sincere thanks to all of the clinical trial investigators, site coordinators and patients in this study for their dedication in helping us complete the clinical development of bempedoic acid for patient with hyperlipidemia.”