Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
Epanova™ Achieved Primary Endpoint for Triglyceride Lowering At All Three Doses (2, 3, 4 grams)
PRINCETON, N.J., April 26, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced positive top-line data from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) clinical study for Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. The Phase 3 clinical trial randomized 399 subjects with triglyceride levels of 500-2000 mg/dl to 2, 3, or 4 grams of Epanova, or 4 grams of olive oil for a total of 12 weeks of treatment. The primary endpoint of the trial was the percentage change in triglyceride level from baseline to week 12, and the secondary endpoint was the reduction in non-HDL-cholesterol. The top-line results demonstrated highly statistically significant reduction of triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2 gram cohort and 31% for those subjects on the 4 gram dose. Furthermore, Epanova appeared safe and well tolerated, with discontinuation rates due to adverse events, primarily gastrointestinal, ranging from 5% to 7% across all dosing groups.
Commenting on the results, Jerry Wisler, Chief Executive Officer and Co-Founder of Omthera, stated, "We are pleased by the comprehensive lipid benefits shown by Epanova in the EVOLVE study - especially at the 2 gram dose, which demonstrated triglyceride lowering comparable to that of 4 gram doses of other prescription omega-3 products. This comparable efficacy of Epanova at a significantly lower dose supports the prior demonstration of improved bioavailability of this free fatty acid formulation versus the ethyl ester form found in other prescription Omega 3 products. The preliminary data also showed dose-dependent increases in plasma EPA and DHA levels with Epanova. We look forward to completing a comprehensive analysis of the study and aim to present the complete data set at an upcoming scientific meeting."
Dr. Michael Davidson, Co-Founder and Chief Medical Officer of Omthera, stated, "In addition to the triglyceride lowering benefit, we were pleased to observe from these top-line results a meaningful decrease of 8% in non-HDL-cholesterol in both the 2 and 4 gram dose groups. We believe these data will be important for Epanova in light of the growing reliance of the medical community (Journal of the American Medical Association, March 28, 2012 – Vol 307, No 12) on non-HDL-cholesterol as the more accurate arbiter of the risk for cardiovascular disease, especially in patients with hypertriglyceridemia. We have recently completed enrollment and randomization in ESPRIT, our 647 patient statin combination study. The primary objective of ESPRIT is to evaluate the efficacy of adding Epanova (2 gram or 4 gram daily) to statin monotherapy for lowering non-HDL-cholesterol. We look forward to the results from this study, expected in July 2012, to further validate the progression of Epanova as a best-in-class therapy for the treatment of patients with mixed dyslipidemia."
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). 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 ≥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.
Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased risk of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with approximately 35 million of those diagnosed with hypertriglyceridemia (triglycerides greater than 200mg/dL) and an estimated 5 million with very high triglyceride levels (triglycerides greater than 500mg/dL). Very high triglycerides are associated with an increased risk of pancreatitis. Regulatory approval for the treatment of very high triglycerides is based on a significant reduction in the serum triglyceride levels.
About Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately held, specialty pharmaceutical 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. 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
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Posted: April 2012