Esperion (NASDAQ:ESPR) reported positive top-line results from a Phase 3 study of its bempedoic acid/ezetimibe combination pill for the treatment of LDL-C lowering.
The study included 382 high-risk patients taking maximally tolerated statins who required additional LDL-C lowering and met its key efficacy endpoints. Among other things,LDL-C lowering of 35% for the combination pill at 12 weeks, compared with 3% for placebo, 24% for ezetimibe 10 mg and 20% for bempedoic acid 180 mg.
“I’m pleased to see the positive safety and tolerability profile of the bempedoic acid/ezetimibe fixed-dose combination pill was similar to that of ezetimibe alone,” Dr. Christie Ballantyne, chairman of Esperion’s Phase 3 executive committee and Prof. and chief of cardiology at Baylor College of Medicine in Houston, said in a statement.
“The LDL-C lowering and high-sensitivity C-reactive proteinreductions seen with the combination are very important to physicians like me who see these challenging patients every day, and we need more options for them,” she added.
In the 12-week study, the combination pill was observed to be safe and well tolerated.
Tim Mayleben, president and CEO of Esperion, said the pivotal study results of the bempedoic acid/ezetimibe combination pill are highly compelling.
“With the combo pill we are confident physicians will have the treatment option they need to help the more than 12 million Americans with high LDL-C already taking maximally tolerated statin therapy, conveniently and cost-effectively achieve lower LDL-C levels,” he added.
