The Plymouth pharmaceutical developer Esperion Therapeutics Thursday 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 of patients with symptoms characterized by metabolic syndrome. The efforts to advance ETC-1002 complement Esperion’s other research and development program, focused on optimizing an HDL therapy in a strategic partnership with the Cleveland Clinic.”
Esperion Therapeutics intends to commercialize innovative, first-in-class therapies focused on promoting cardio-metabolic health.
More at www.esperion.com.