Omthera Pharmaceuticals, Inc. Announces Invitation to Attend Presentation of the Complete Data Sets from its Phase 3 EVOLVE and ESPRIT Clinical Studies
Published: Nov 02, 2012
PRINCETON, N.J., Nov. 2, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced an invitation to attend the presentation of data from its Phase 3 clinical studies. The presentation will be held on November 5, 2012 at 7:30 a.m. pst in the Bernards Room at the Millennium Biltmore Hotel, 506 South Grand Avenue, Los Angeles. Participants are also invited to attend the presentation via a live webcast available through the "What's New" section at www.Omthera.com. The webcast will be available for replay following the presentation.
The Phase 3 EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial was a 12 week, multi-center, randomized, double-blind, study of 399 patients, evaluating the efficacy and safety of three doses of Epanova in patients with fasting triglyceride levels of at least 500 mg/dL but less than 2000 mg/dL. Patients were randomized into four dosing groups: Epanova 2g/day; Epanova 3g/day; Epanova 4g/day; and control (olive oil 4 g/day). 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-C.
The Phase 3 ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) trial was a six-week, randomized, double-blind, parallel group study of 647 patients to assess the efficacy and safety of add-on Epanova to statin therapy in patients with persistent hypertriglyceridemia and high risk for cardiovascular disease. Patients were randomized into three dosing groups; Epanova 2g/day; Epanova 4g/day; and control (olive oil 4 g/day). The primary objective of the study was to evaluate the efficacy of adding Epanova (2g or 4g daily) to statin monotherapy for lowering Non-HDL-C. Secondary objectives are to evaluate the safety of the Epanova and statin combination therapies, and to evaluate the effects of the combination therapies on TG and other lipids and lipoproteins.
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 40 million of those diagnosed with hypertriglyceridemia (triglycerides greater than 200mg/dL) and an estimated 4 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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