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.

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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.

"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."

"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.

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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.