Omthera Pharmaceuticals, Inc. a privately-held emerging specialty pharmaceuticals company, announced that it has completed enrollment in its Phase 3 EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) clinical trial for Epanova, the company’s lead compound for the treatment of patients with very high triglycerides. This study is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration. Initial top-line data from the Phase 3 study is expected to be available in April 2012.
The Phase 3 EVOLVE trial is a 12 week, multi-center, randomized, double-blind, placebo-controlled study, evaluating the efficacy and safety of three doses of Epanova in patients with fasting triglyceride (TG) levels of ?500 mg/dL. Subjects in the trial have been randomized into four groups: Epanova 2 g/day; Epanova 3 g/day; Epanova 4 g/day; or 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 to non-HDL cholesterol.
Dr. Michael Davidson, Chief Medical Officer and co-Founder of Omthera, said, “The prevalence of severe hypertriglyceridemia, globally, has risen dramatically over the past decade. Currently, approximately 1.7% of the U.S. population, alone, suffers from severe hypertriglyceridemia, equating to roughly 5 million Americans—less than 20% of whom are receiving lipid lowering therapy. This represents a severe unmet medical need, which can be addressed by a more effective prescription Omega-3. We believe that Epanova will provide the best solution to this rapidly increasing health care problem.”
Date: November 29, 2011
Source: Omthera Pharmaceuticals, Inc.