Esperion Announces Positive Topline Results from Phase 2 Diabetes Clinical Trial
News Jan 10, 2013
Esperion Therapeutics announced positive results of a recently completed Phase 2 clinical trial of ETC-1002 in patients with type 2 diabetes with LDL-C lowering of up to 43% compared to placebo. ETC-1002 therapy was also associated with improvements in control of additional cardiometabolic risk factors in this high-risk, difficult-to-treat patient population. The full data from this Phase 2 clinical trial will be presented at a future scientific meeting.
ETC-1002 is an investigational, once-daily, oral small molecule therapy that has been shown to be liver selective for activation of AMP kinase and inhibition of ATP citrate lyase. This dual mechanism of action has the potential to regulate imbalances in both hepatic lipid and carbohydrate metabolism. In the Phase 2 trial, 60 patients with type 2 diabetes received ETC-1002 or placebo for four weeks in an inpatient facility. In clinical research to date, ETC-1002 has shown an attractive safety profile, significant and consistent LDL-C lowering and beneficial effects on hsCRP, glucose and other cardiometabolic risk factors. ETC-1002 is currently being studied in multiple Phase 2 clinical trials.
“With these results, ETC-1002 has now been shown to be safe and well-tolerated in two Phase 2 studies. We continue to rapidly advance ETC-1002 through Phase 2 clinical development and we are exploring its efficacy in additional patient populations, with a particular focus on the growing statin-intolerant patient population. We look forward to presenting our clinical results in peer-reviewed settings later this year,” said Tim Mayleben, president and CEO of Esperion.
“People living with type 2 diabetes are at high risk for cardiovascular disease. For many, treatment with statins and other cardiometabolic therapies can impair glycemic control, potentially putting them at increased risk. With a novel mechanism of action designed to lower LDL-C and provide beneficial effects on glucose control, ETC-1002 has the potential to offer significant advantages for patients living with type 2 diabetes and for patients who are statin intolerant and/or not at the appropriate National Cholesterol Education Program (NCEP) LDL-C goal,” said Dr. Roger Newton, executive chairman and chief scientific officer of Esperion.