PLYMOUTH, Mich., Jan. 6, 2011 /PRNewswire/ — Esperion
Therapeutics, a privately held biotechnology company working to
discover, develop and commercialize treatments for cardiovascular
and metabolic diseases, today announced that it has initiated a
Phase 2 clinical study for ETC-1002, the company’s lead product
candidate. ETC-1002 is a novel small molecule compound that has
demonstrated preclinical and clinical activity as a metabolic
regulator of imbalances in lipid and carbohydrate metabolism. The
compound acts to inhibit fatty acid and cholesterol synthesis and
enhance fatty acid oxidation. ETC-1002 has the potential to
regulate LDL-C, HDL-C, triglycerides, glucose/insulin and other
cardio-metabolic risk factors.
The 12-week, multi-site, randomized, double-blind, placebo
controlled study will enroll 176 patients with
hypercholesterolemia, with or without high triglycerides, to assess
the role of ETC-1002 in lipid regulation (LDL-C and triglycerides).
This Phase 2 trial builds on positive data from the Phase 1 program
in which ETC-1002 demonstrated a statistically significant lowering
of LDL-C in mildly dyslipidemic subjects and a favorable safety
profile in both single and multiple-dose studies in more than 70
patients. A second Phase 2 clinical study is planned in 2011 to
validate other attributes observed in preclinical studies with
ETC-1002 which further support its pharmacological effects as a
metabolic regulator.
“Cardio-metabolic diseases remain the leading cause of morbidity
and mortality among men and women in industrialized countries
worldwide,” said Roger Newton, PhD, President and CEO of Esperion.
“Our preclinical research has shown ETC-1002 regulates lipids,
atherosclerosis, inflammation and glucose/insulin. These data,
along with the accumulating clinical evidence, suggest that
ETC-1002 may be an effective therapy to regulate metabolic
imbalances in lipid and carbohydrate metabolism and could play a
significant role in the treatment
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