Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) Phase III clinical trial of Epanova™, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin. The trial has been granted a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration.
Epanova, a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is Omthera's lead compound, currently in development as a prescription omega-3 free fatty acid for the treatment of patients with very high triglycerides (greater than or equal to 500 mg/dL). The Company's Pivotal Phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for this indication, which received SPA approval in November 2010, is ongoing, and will form the basis for filing a new Drug Application ("NDA") with the U.S. Food & Drug Administration. The results of the ESPRIT trial are not required for regulatory approval, but rather, if positive, would serve to expand the use of Epanova to a larger patient population.
The Phase III ESPRIT trial will be a six-week, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of add-on Epanova to statin therapy in patients with persistent hypertriglyceridemia despite statin therapy and who remain at high risk for cardiovascular disease. The primary objective is to evaluate the efficacy of adding Epanova (2g or 4g daily) to statin monotherapy for lowering Non-HDL cholesterol ("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 other lipids and lipoproteins. The trial is expected to enroll 642 subjects and will be conducted at approximately 100 sites in the U.S.
Principal investigator for the ESPRIT study, Dr. Stephen Nicholls, Assistant Professor of Molecular Medicine and the Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research and a consultant for Omthera Pharmaceuticals, noted, "Millions of Americans treated with statins, are still at risk for cardiovascular events. Non-HDL-C is an important target of drug therapy for patients on a statin with TG between 200 and 500 mg/dL. The results of this trial, if positive, could further support the use of omega-3 free fatty acids as a treatment for these patients."
Dr. Michael Davidson, Chief Medical Officer and co-Founder of Omthera, stated, "The development of Epanova, which has the potential to become the best in class omega-3 fatty acid, is well underway. Data generated earlier this year demonstrated that Epanova has superior bioavailability compared to the market leader, Lovaza®, and our EVOLVE trial, intended to support our planned NDA filing, has been actively enrolling subjects. Today, with the initiation of the ESPRIT trial, we have now taken a further step to potentially expand the indication to include patients with persistent hypertriglyceridemia and high risk for cardiovascular disease, who are on statin therapy, for which there are currently no approved prescription omega-3 drugs."