Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
The multi-center, placebo-controlled, randomized, double-blind, 12-week study will evaluate the efficacy and safety of three doses of Epanova in patients with fasting triglyceride (TG) levels of greater than or equal to 500 mg/dL. The trial is expected to enroll approximately 300 patients and will be conducted in centers throughout North America, Europe and India. The primary endpoint of the trial, known as EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs), is the percentage change in triglyceride level from baseline to week 12.
"An estimated five million people in the U.S., alone, have triglyceride levels greater than 500 mg/dL, a serious lipid disorder that is rapidly growing in prevalence throughout the world," said Jerry Wisler, President and Chief Executive Officer of Omthera. "This SPA marks an important milestone for Omthera, providing a clear regulatory pathway to approval for Epanova in this patient population. We look forward to commencing this Phase III trial in the coming months."
In addition to the EVOLVE study, Omthera has initiated a pharmacokinetic trial for Epanova, known as ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic, Single-dose Evaluation), intended to demonstrate bioavailability advantages over currently available prescription Omega 3 products. Data from this study is expected in the first quarter of 2011.
"Cardiovascular disease continues to be the leading cause of death worldwide, and high triglycerides are an important contributing factor," said 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 principal investigator for the EVOLVE study. "Epanova therefore has the potential to be an innovative therapy to help patients control their triglyceride levels."
About Epanova™
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 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 Hypertriglyceridemia
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 over 27 million of those diagnosed with hypertriglyceridemia (TGs greater than 200 mg/dL) and an estimated 5 million with very high triglyceride levels (TGs greater than 500 mg/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.
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