Esperion Publishes Bempedoic Acid Study 3 Results

– Study 3 Demonstrated Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP in Patients Considered Statin Intolerant –– Over 24-Weeks, Bempedoic Acid Was Observed to be Safe, Well-Tolerated, and the Muscle-Related Adverse Event Rate Did Not Differ from Placebo –– Bempedoic Acid Is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid Synthesis in the Liver –– Research by Ulrich Laufs, MD, PhD published in the Journal of the American Heart Association –

Esperion (NASDAQ:ESPR) announced today that results from the 345 patient, 24-week, Phase 3, double-blind, placebo-controlled study of bempedoic acid (CLEAR Serenity, also known as Study 3) were published today in the Journal of the American Heart Association (JAHA). Bempedoic acid is being developed as a complementary, cost-effective, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C).  Bempedoic acid and the bempedoic acid / ezetimibe combination tablet new drug applications have been submitted to the United States Food and Drug Administration, as well as are under regulatory review for marketing authorization by the European Medicines Agency.

Study 3 evaluated the efficacy, safety, and tolerability of bempedoic acid 180 mg versus placebo in 345 patients with hypercholesterolemia and considered statin intolerant (history of intolerance to at least two statins).

The JAHA publication highlights results from the primary efficacy endpoint of LDL-C lowering at 12-weeks and key secondary endpoints of safety and tolerability over 24-weeks, including that bempedoic acid (BA):

• significantly lowered LDL-cholesterol by 21 percent;
• significantly reduced high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 25 percent;
• was observed to be safe and well-tolerated;
• did not induce muscle symptoms in statin intolerant patients compared with placebo (BA 12.8% vs placebo 16.2%);
• showed an adverse event rate of 64.1% compared with a placebo event rate of 56.8%, a serious adverse events rate of 6.0% compared with a placebo event rate of 3.6%, with no serious adverse events considered related to study medication;
• showed numerically fewer new-onset or worsening of diabetes compared with the placebo group (BA 2.1% vs 4.5% placebo)

https://www.marketscreener.com/ESPERION-THERAPEUTICS-INC-13479951/news/Esperion-Announces-Publication-in-The-Journal-of-the-American-Heart-Association-of-Bempedoic-Acid-St-28332989/