ESPR reports initial results from Phase 2 of ETC-216 for regression of Atherosclerosis:
>>Regression of Atherosclerosis Seen with ETC-216 (AIM)
Thursday June 26, 7:01 am ET
Esperion announces initial study results showing use of HDL mimetic decreases percent plaque volume in coronary arteries.
ANN ARBOR, Mich., June 26 /PRNewswire-FirstCall/ -- Esperion Therapeutics, Inc. (Nasdaq: ESPR - News), a biopharmaceutical company focused on discovering and developing high-density lipoprotein (HDL) -targeted therapies for the treatment of cardiovascular disease, today announced initial results from a multiple-dose, multi-center Phase II clinical study of its investigational product ETC-216 (AIM or ApoA-I Milano/phospholipid complex) in patients with acute coronary syndromes (ACS). The study met its primary efficacy objective of demonstrating statistically significant regression of atherosclerosis with ETC-216.
The purpose of this clinical trial was to investigate whether ETC-216 was effective in regressing coronary atherosclerosis. Changes in plaque size were measured using intravascular ultrasound (IVUS). In IVUS, a tiny ultrasound probe is inserted into the coronary artery to directly image atherosclerotic plaques. The trial was a randomized, double-blind study evaluating the efficacy of ETC-216 at two different levels of intravenous infusions (15 mg/kg and 45 mg/kg), compared to placebo, administered every seventh day for a maximum of five doses. The study evaluated forty-seven patients with ACS, who were scheduled to undergo coronary angiography. The primary endpoint was the change in percent atheroma (plaque) volume for the evaluable patients in the combined ETC-216 treatment arms comparing end-of-treatment values to baseline values as measured with IVUS.
The trial was conducted in conjunction with the Cleveland Clinic Foundation, one of the largest and most respected cardiovascular centers in the United States. Steven E. Nissen, M.D., F.A.C.C., Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center, served as the study's principal investigator. Other centers participating in the study included Integris Southwest Hospital in Oklahoma City, Oklahoma; Borgess Medical Center in Kalamazoo, Michigan; Mid Ohio Heart Clinic in Mansfield, Ohio; North Ohio Heart Center in Elyria, Ohio; William Beaumont Hospital in Royal Oak, Michigan; Medical College of Ohio in Toledo, Ohio; and Radiant Research in Santa Rosa, California.
Further details regarding the results of this trial will be available at the time of presentation of the complete study results (pending additional efficacy parameters as well as safety and tolerability analyses) at an appropriate scientific meeting and/or publication in a peer reviewed journal.
ApoA-I Milano is a variant of ApolipoproteinA-I (ApoA-I), the major protein component of HDL. HDL is believed to effectively protect against cardiovascular disease by efficiently removing cholesterol and other lipids from artery walls and other tissues and transporting them to the liver for elimination. The mechanism of AIM as a human recombinant protein complexed to phospholipid is to mimic HDL and its function in a process called reverse lipid transport (RLT). ApoA-I Milano is present in a small population of northern Italians with paradoxically low levels of HDL-cholesterol. Low HDL- cholesterol levels normally would correlate with high risk for cardiovascular disease, but carriers of the ApoA-I Milano gene show a reduced risk, presumably due to enhanced RLT.
Esperion Therapeutics
Esperion Therapeutics, Inc. discovers and develops pharmaceutical products for the treatment of cardiovascular disease. Esperion intends to commercialize a novel class of drugs that focuses on a new treatment approach called "HDL Therapy," which is based on the Company's understanding of high- density lipoprotein, or HDL, function. HDL is the primary facilitator of the RLT pathway by which excess cholesterol and other lipids are removed from arteries and other tissues and are transported to the liver for elimination from the body. Esperion's goal is to develop drugs that exploit the beneficial functions of HDL within the RLT pathway. Esperion currently has several product candidates under development for the treatment of cardiovascular disease. Esperion is listed on the Nasdaq National Market under the symbol "ESPR." For more information, visit www.esperion.com [snip]<<
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