Esperion Therapeutics Inc. said its cholesterol medicine met the main goal of a late-stage study.
The company was studying bempedoic acid in a late-stage trial known as Study 4, which enrolled 269 patients either with, or at a high risk of, the atherosclerotic cardiovascular disease, or ASCVD, which raises their possibility of having a heart attack. The medicine was given in addition to Merck & Co. Inc.'s Zetia, also called ezetimibe.
These patients were intolerant to a class of drugs known as statins, which lower blood cholesterol by reducing its production inside the liver but can also cause serious side effects such as liver failure and death of muscle tissue.
After 12 weeks, patients who received bempedoic acid had a 23% reduction in their low-density lipoprotein cholesterol, or LDL-C, which is also known as bad cholesterol. This would compare to a 5% increase in cholesterol levels in the group that received placebo. When combined, the overall effect was a 28% improvement compared with placebo.
Patients treated with bempedoic acid also achieved a significantly greater reduction of 33% in high-sensitivity C-reactive protein, which is the underlying inflammation associated with cardiovascular disease. This would compare to a 2% increase for the placebo group.
The Ann Arbor, Mich.-based company said the medicine was observed to be safe and well-tolerated. The drug is also being studied in other trials, with results expected sometime later this year.
The company will seek regulatory approval of the drug in the U.S. and the EU in 2019.
