Esperion Announces Publication of Bempedoic Acid Study 1 Results in The New England Journal of Medicine

On Mar 13, 2019

Esperion announced that results from the 2,230 patient, 52-week, Phase 3 long-term safety study of bempedoic acid (CLEAR Harmony, also known as Study 1 or 1002-040) were published today in The New England Journal of Medicine (NEJM). 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 1 evaluated the long-term safety, tolerability and efficacy of bempedoic acid 180 mg versus placebo in 2,230 high-risk patients with atherosclerotic cardiovascular disease (ASCVD) that are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statins.

The NEJM publication highlights results from the primary endpoint of adverse event rates over 52-weeks along with key efficacy endpoints at 12-weeks, including that bempedoic acid:

significantly lowered LDL-cholesterol by 18 percent on background maximally tolerated statin therapy;
significantly reduced high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, by 22 percent;
did not lead to higher overall adverse events compared with placebo (BA 78.5% vs placebo 78.7%), and the proportion of patients with reported serious adverse events was small and similar compared with placebo (BA 14.5% vs placebo 14.0%);
showed fewer adjudicated major adverse cardiac events compared with placebo (BA 4.6% vs placebo 5.7%);
showed lower rates of new-onset or worsening of diabetes compared with placebo (BA 3.3% vs 5.4% placebo);
was observed to be safe and well-tolerated.

“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,” said Bill Sasiela, Senior Vice President, Clinical Development at Esperion.

“This latest study shows that bempedoic acid could be another addition to the arsenal of once-daily, oral cholesterol-lowering treatments available to patients. Overall, these recent studies show that not only is the treatment generally well-tolerated, being comparable with placebo, and potentially safe over longer periods, but that when added to high intensity statin treatment it can help to further reduce LDL-cholesterol levels,” said Professor Kausik Ray, from the Imperial Centre for Cardiovascular Disease Prevention at Imperial College London’s School of Public Health, who led the study. “Whilst this was not an outcomes study, our parallel paper in the same issue of the Journal suggests comparing the mechanism of cholesterol lowering with bempedoic acid with statins using genetics suggests that we can hope to expect similar benefit to statins per mmol/L lowering of LDL-cholesterol. The ongoing trial, ‘CLEAR OUTCOMES’, is specially testing even longer-term safety and whether this approach reduces cardiovascular disease risk in addition to lowering cholesterol.”