Omthera Pharmaceuticals Reports Favorable Pharmacokinetics Data from ECLIPSE Trial
Epanova™ Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation
BEDMINSTER, N.J., Jan. 7, 2011 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced data from its ECLIPSE trial (Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation), designed to evaluate the bioavailability of Epanova™, the Company's lead compound for the treatment of very high triglycerides (greater than or equal to 500 mg/dL), in comparison to Lovaza®, the leading prescription Omega 3. Epanova is an Omega 3 fatty acid compound containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
The primary objective of the 54 subject, randomized, open-label, four-way cross-over pharmacokinetics (PK) study, was to compare the bioavailability of EPA and DHA over 24 hours from either Epanova and Lovaza as single 4-gram doses with low- or high-fat diets.
Data from the trial showed that the bioavailability of Epanova was dramatically superior to Lovaza. Specifically, the plasma level of EPA+DHA in subjects on a low-fat diet who received Epanova was over four times higher than those given Lovaza. Epanova also demonstrated significantly higher EPA+DHA levels than Lovaza on a high-fat diet. In a separate analysis, Epanova demonstrated a 13-fold increase in bioavailability of EPA over Lovaza in subjects consuming a low-fat diet in this study.
Commenting on today's news, Dr. Michael Davidson, Chief Medical Officer and co-founder of Omthera Pharmaceuticals, noted, "We are extremely pleased with the very impressive results generated by this head-to-head comparative bioavailability study, which, for the first time, demonstrate that Epanova, a free fatty acid (FFA) form of EPA and DHA, has significantly better bioavailability than Lovaza, an ethyl ester EPA and DHA product, in subjects on a high-fat diet; and dramatically higher bioavailability in subjects consuming a low-fat diet. The ECLIPSE study demonstrates that Lovaza is poorly absorbed in patients on a low-fat diet. We believe that this finding will have significant clinical importance because patients with severe hypertriglyceridemia should be maintained on a low-fat diet. The data from this study clearly demonstrates that Epanova will provide superior blood levels of Omega 3's with both low- and high-fat diets."
"The results of Omthera's ECLIPSE study confirm the superior absorption profile of Epanova versus the only currently marketed prescription Omega 3 therapy, and is the last step in our development program prior to initiating a pivotal Phase 3 trial evaluating Epanova in patients with very high triglycerides, which we aim to begin during the first quarter of 2011," said Jerry Wisler, President, Chief Executive Officer, and co-founder of Omthera.
John J. P. Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the Department of Vascular Medicine at the Academic Medical Center (AMC) of the University of Amsterdam, and a member of Omthera's Scientific Advisory Board, stated, "While studies have shown that FFA forms of Omega 3 have superior bioavailability versus others, including the currently prescribed ethyl ester formulation found in Lovaza, the positive PK results generated by Omthera's ECLIPSE study are even more notable than I had expected. The data strongly suggest that Epanova could ultimately represent an important improvement in the management of patients suffering from severe hypertriglyceridemia. I look forward to the continued development of this novel prescription Omega 3."
Dr. Davidson concluded, "The dramatic rise in obesity over the last 10 to 20 years has led to a concomitant increase in triglyceride levels among the population and a shift in clinician's awareness to the critical role that high triglyceride levels have as a predictor of cardiovascular events. Since patients with very high triglycerides should be placed on a low-fat diet, an Omega 3 product that is better absorbed with a low-fat diet, as Epanova has demonstrated in the ECLIPSE study, would likely be a significant improvement over the ethyl ester Omega 3s."
Mr. Wisler will provide an overview of these results at the 29th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on Thursday, January 13, 2011 at 10:30 am PT, as well as at the 8th Annual Bio Asia International Partnering Conference, on January 25, 2011 at the Grand Hyatt Tokyo, in Tokyo, Japan.
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Free fatty acids are the chemical form in which essential fatty acids are absorbed in the digestive tract. Ethyl esters require enzymatic conversion prior to absorption, and release of these pancreatic enzymes requires the triggering event of fat-containing food intake. Omthera has developed a substantial body of data on Epanova, which points to an improved and more predictable bioavailability as compared to the ethyl ester form found in prescription Omega 3 products currently available. Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's Disease patients with normal triglyceride levels for greater than or equal to 52 weeks; approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability profile.
About Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately-held, emerging specialty pharmaceuticals company focusing its efforts on the clinical development of new therapies for dyslipidemia. Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease. The lead product candidate is Epanova, an Omega 3 fatty acid compound preparing to enter Phase III clinical development as a triglyceride-lowering adjunct therapy to diet in patients with very high triglycerides (greater than or equal to 500 mg/dL). Future planned clinical trials for Epanova include patients with high triglycerides (greater than or equal to 200 mg/dL and less than or equal to 500 mg/dL) currently on statin therapy. Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss Company that is the owner of the product. For more information, please visit www.omthera.com.
SOURCE Omthera Pharmaceuticals, Inc.
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