Omthera Pharmaceuticals Initiates Pivotal Phase III EVOLVE Trial for Epanova™ in Patients with Very High Triglycerides EpanoVa fOr Lowering Very high triglyceridEs
BEDMINSTER, N.J., March 14, 2011 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been dosed in its pivotal Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for 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 Phase III trial was granted a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration, which Omthera announced via a press release in November 2010.
The Phase III EVOLVE trial is a 12 week multi-center, randomized, double-blind, placebo-controlled study that 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, which will be the largest of its kind conducted in this patient population to date, is expected to enroll approximately 330 patients and is being conducted in 60 centers throughout North America, Europe and India. Subjects will be randomized into four groups as follows: (1) Epanova 2g/day; (2) Epanova 3g/day; (3) Epanova 4g/day; or (4) placebo 4 caps/day. The primary endpoint of the trial is the percentage change in triglyceride level from baseline to week 12. The secondary endpoint is the reduction of non-HDL cholesterol.
Omthera recently announced results of the ECLIPSE (Epanova Compared to Lovaza In a Pharmacokinetic Single-dose Evaluation) study in which Epanova, a free fatty acid form of EPA and DHA was shown to produce dramatically superior bioavailability compared to Lovaza®, an ethyl esther EPA and DHA product which is the only currently available prescription Omega-3 on the market. The plasma levels of EPA+DHA in subjects on a low-fat diet who received Epanova were more than four times higher than levels in those given Lovaza. In a separate analysis of the data, Epanova demonstrated a 13-fold increase in bioavailability of EPA over Lovaza in subjects consuming a low-fat diet.
Commenting on today's news, Dr. Michael Davidson, Chief Medical Officer and co-founder of Omthera Pharmaceuticals, noted, "The dosing of the first patient in the EVOLVE trial is another significant milestone in the clinical development of Epanova. Given its positive clinical profile demonstrated thus far, Epanova could offer physicians the option of prescribing a significantly lower dosage of drug to patients (2g/day), with a more predictable absorption profile and the ability to titrate up, when needed, for further triglyceride lowering. These characteristics, including the potential for better patient compliance, could ultimately make Epanova a best-in-class Omega-3 therapy for patients suffering from very high triglycerides."
John J. P. Kastelein, M.D., Ph.D., a Co-Principal Investigator of the EVOLVE study and Professor of Medicine and Chairman of the Department of Vascular Medicine at the Academic Medical Center (AMC) of the University of Amsterdam, stated, "As obesity rates have risen, the number of patients suffering from hypertriglyceridemia has likewise increased, making the need for a more effective and convenient treatment option even more important. The results of Omthera's Epanova studies thus far have been highly encouraging. Epanova could represent a major new treatment alternative and I am, therefore, delighted to be involved in this important Phase III trial."
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, including the results of its ECLIPSE study mentioned above, which points to an improved and more predictable bioavailability for Epanova 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.
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 200mg/dL) and an estimated 5 million with very high triglyceride levels (TGs 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, 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 Company recently initiated a pivotal Phase III clinical trial for its lead product candidate, Epanova, an Omega-3 fatty acid compound in 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 greater 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.