Esperion Therapeutics said the phase 3 long-term safety study showed that bempedoic acid has significantly reduced low-density lipoprotein cholesterol (LDL-C), as well as high-sensitivity C-reactive protein (hsCRP).
Esperion said that bempedoic acid is under development as a complementary, cost-effective, once-daily and oral therapy to treat patients with elevated LDL-C.
The company has submitted new drug applications for the bempedoic acid and the bempedoic acid / ezetimibe combination tablet with the US Food and Drug Administration. Both are also under regulatory review for marketing authorization by the European Medicines Agency
Bempedoic acid is an oral and once-daily ATP Citrate Lyase (ACL) inhibitor, which reduces cholesterol and fatty acid synthesis in the liver.
The study assessed the long-term safety, tolerability and efficacy of bempedoic acid 180mg against placebo in 2,230 high-risk patients with atherosclerotic cardiovascular disease (ASCVD).
The results from the 52-week study showed that bempedoic acid significantly lowered LDL-cholesterol by 18% on background maximally tolerated statin therapy and also significantly reduced hsCRP by 22%, which is an important marker of the underlying inflammation associated with cardiovascular disease
Esperion clinical development senior vice president Bill Sasiela said: “The publication of the largest bempedoic acid study to date further confirms what leading experts have said, that bempedoic acid is a safe, well-tolerated and efficacious potential treatment option that can significantly lower LDL-cholesterol as well as reduce hsCRP.”
The global and pivotal phase 3 randomized, double-blind, placebo-controlled and multicenter study assessed the long-term safety and tolerability of bempedoic acid 180 mg/day versus placebo in high-risk patients with ASCVD or heterozygous familial hypercholesterolemia (HeFH) with LDL-C levels of at least 70 mg/dL who are inadequately controlled with current lipid-modifying therapies.
Esperion carried out the study at 117 sites in the US, Canada and Europe, and randomized 2,230 patients in 2:1 to receive bempedoic acid or placebo.
The secondary objective of the study was to evaluate the 12-week LDL-C lowering efficacy of bempedoic acid against placebo, while tertiary objectives were to assess the effect of bempedoic acid on other lipid parameters and risk markers.
The study head professor Kausik Ray said: “This latest study shows that bempedoic acid could be another addition to the arsenal of once-daily, oral cholesterol-lowering treatments available to patients.”