Esperion Therapeutics, a clinical-stage biopharmaceutical company, has announced positive results from Phase IIa study of ETC-1002 in patients with hypercholesterolemia and history of intolerance to two or more statins.
The study’s primary endpoint was met, with participants treated with ETC-1002 experiencing lowered low-density lipoprotein cholesterol (LDL-C) by an average of 32%, compared with an LDL-C reduction of 3% in the placebo group.
Hartford Hospital cardiovascular research cardiology director and the University of Connecticut professor of medicine Dr Paul Thompson said the level of LDL-C reduction is comparable to what was seen with mid-dose statins.
"These patients have very limited therapeutic options. Therefore, a well-tolerated medication that significantly lowers LDL-C could benefit this underserved patient population," Thompson said.
Designed to assess ETC-1002’s LDL-C lowering efficacy, safety and tolerability profile against placebo, the study randomised 37 patients with the investigational agent and 19 patients with placebo.
Participants received 60mg, 120mg, 180mg and 240mg for two weeks each or placebo only for eight weeks.
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Following the eight-week ETC-1002 therapy, the recognised marker for inflammation high sensitivity C-reactive protein (hsCRP) was significantly reduced and similar adverse event rates were found between the ETC-1002 and placebo groups.
The Phase IIb study, designed to assess multiple doses of ETC-1002 in a parallel group design of up to 12 weeks in duration with ezetimibe, is planned to commence by the end of 2013 in patients with hypercholesterolemia and a history of statin intolerance.