Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced positive results from a Phase 2 clinical trial for ETC-1002. This novel small molecule activator of AMP Kinase has demonstrated preclinical and clinical activity as a metabolic regulator of imbalances in lipid and carbohydrate metabolism. Results were presented today in an oral presentation at the 2012 American College of Cardiology meeting in Chicago.
In this 12-week, randomized, multi-center, double-blind, placebo controlled study, 177 dyslipidemic subjects were evaluated to assess the lipid regulating safety and efficacy of ETC-1002. The primary objective of the study was to assess the LDL-C lowering using daily doses of ETC-1002 up to 120 mg/day or placebo for the duration of the study. Secondary objectives included assessing the ability of ETC-1002 to lower plasma triglycerides and to beneficially modulate other lipid and non-lipid biomarkers. In addition, safety and tolerability and pharmacokinetic analyses were performed. Results from the Phase 2 trial show that in subjects treated with ETC-1002, LDL-C levels were maximally decreased up to 27% after two weeks of treatment and was sustained over the remaining ten weeks. Other relevant biomarkers, including Apo B, LDL-P (NMR) and nonHDL-C, were also significantly decreased.
According to the Cardiometabolic Disease Association, an estimated 47 million Americans have cardio-metabolic disease. New tools and effective treatment strategies are needed to prevent, delay and manage cardio-metabolic disease and address this growing health problem. The Phase 2 study results also indicate that ETC-1002 was safe and well-tolerated in the subjects tested. Post-hoc analyses demonstrated that ETC-1002 had beneficial effects on insulin, hsCRP and blood pressure.
"These clinically meaningful data indicate that ETC-1002 rapidly regulated plasma lipids, blood pressure, inflammation and insulin in subjects with dyslipidemia," said Roger Newton PhD, president and CEO of Esperion. "While statin therapy is the gold standard, many patients require additional treatment options to reach their ATP III LDL-C goals. These findings also support ETC-1002 as a potential new agent to not only lower LDL-C, but also beneficially regulating other cardio-metabolic risk factors in pre-diabetic and diabetic dyslipidemic patients. We look forward to advancing ETC-1002 to the next stage of clinical development to further investigate its pharmacological effects as a metabolic regulator at higher doses."
"These are promising results with clinically meaningful improvements in LDL-C and other measures of atherogenic lipoproteins -- and with good tolerability and safety," said Christie M. Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart & Vascular Center and the director of The Maria and Alando J. Ballantyne, M.D., Atherosclerosis Clinical Research Laboratory at the Baylor College of Medicine. "These results provide the rationale for larger and longer studies to learn more about the safety limits of this drug, and to look at whether this drug augments traditional statin treatments."
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