Esperion has reported positive data from the long-term Phase III clinical trial of bempedoic acid in patients with elevated low-density lipoprotein cholesterol (LDL-C).
The trial data showed that the drug lowered LDL-cholesterol by 18% in patients who were on background maximally tolerated statin therapy.
It also led to a 22% reduction in high-sensitivity C-reactive protein (hsCRP).
The trial did not show higher overall adverse events in the investigational arm compared to placebo. Bempedoic acid was observed to be safe and well-tolerated.
Bempedoic acid is intended to provide a complementary once-daily oral therapy. It is an ATP Citrate Lyase inhibitor designed to decrease cholesterol biosynthesis and lower LDL-C by up-regulating the LDL receptor.
The Phase III trial assessed the long-term safety, tolerability, and efficacy of a 180mg dose of the drug in a total of 2,230 high-risk patients with atherosclerotic cardiovascular disease (ASCVD) at 117 centres in the US, Canada, and Europe.
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It recruited patients who had inadequate response with existing lipid-modifying treatments.
Data from the trial has been published in The New England Journal of Medicine (NEJM).
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 company has submitted new drug applications to the US Food and Drug Administration (FDA) for bempedoic acid monotherapy and in combination with ezetimibe.
The European Medicines Agency (EMA) is also reviewing their marketing authorisation filings.