Esperion Therapeutics Inc announced the initiation of a second Phase I clinical study of its RLT Peptide product candidate (ETC-642) in patients with existing vascular disease. This study is designed to evaluate the safety and tolerability of ETC-642 at higher dose levels than those evaluated in the first clinical study.

This trial is a randomized, double-blind, placebo-controlled, dose- escalating study of up to twenty patients with stable atherosclerosis. In addition to safety and tolerability, the study will evaluate the pharmacokinetics and lipid effects of three dose levels of a single intravenous infusion of ETC-642. This trial will be conducted at Mayo Clinic. Mehmood A. Khan, an endocrinologist and Director, Diabetes, Endocrine and Nutrition Clinical Trials Unit at the Mayo Clinic, will serve as the principal investigator of the study.

"We are pleased that the positive safety profile in the first clinical trial of ETC-642 has given us the opportunity to evaluate higher doses of ETC- 642 in this study," stated Roger S. Newton, President and CEO of Esperion. "With the data from this second study, we can design the protocol for a multiple dose study in patients for ETC-642."

ETC-642 mimics the biological properties of apolipoprotein A-I, the major protein in HDL, to promote cholesterol removal from arterial walls and other tissues and enhance reverse lipid transport. ETC-642 is a complex of peptide and phospholipids that mimics the functions of natural HDL and is being developed for the treatment of acute coronary disease. ETC-642 has been shown to increase HDL-cholesterol levels and to enhance cholesterol mobilization in preclinical studies and the first Phase I clinical study. Because of these properties, Esperion believes that the administration of ETC-642 may stimulate cholesterol removal in patients.