Esperion Therapeutics' Phase 2a clinical study of ETC-1002 has met the primary endpoint of lowering low-density lipoprotein cholesterol (LDL-C) by an average of 32% compared with an LDL-C reduction of 3% in the placebo group.
Conducted in 56 patients with hypercholesterolemia and a history of intolerance to two or more statins, the study demonstrated considerable tolerability profile of the investigational candidate.
Following an eight-week ETC-1002 therapy, high sensitivity C-reactive protein (hsCRP) was significantly reduced in the study that reported similar adverse event rates in both the groups.
University of Connecticut professor of medicine and Hartford Hospital cardiovascular research cardiology director Paul Thompson said the LDL-C reduction is as comparable to what is seen with mid-dose statins.
"These patients have very limited therapeutic options," Thompson added.
"Therefore, a well-tolerated medication that significantly lowers LDL-C could benefit this underserved patient population."
With an objective to demonstrate comparable tolerability and superior efficacy of ETC-1002 to ezetimibe, a Phase 2b study is expected to be conducted in statin intolerant patients in the fourth quarter of 2013.