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."