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The trial is called EVOLVE and will evaluate the efficacy and safety of the drug, geared to patients with very high triglycerides.
On March 14, new pharmaceutical company Omthera Pharmaceuticals announced it had begun its Phase III clinical trial for its new Epanova omega-3 pharmaceutical, geared to patients with very high triglycerides. The trial is called EVOLVE (Epanova For Lowering Very High Triglycerides) and will evaluate the efficacy and safety of the drug.
The drug contains a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3. The company says that the Phase III trial was granted a Special Protocol Assessment from FDA.
The trial is a 12-week multicenter, randomized, double-blind, placebo-controlled study that will administer Epanova to patients with fasting triglyceride levels greater than or equal to 500 mg/dL. The subjects will be randomized to receive a placebo or either 2, 3, or 4 g of Epanova daily.
The study expects to enroll approximately 330 patients and is being conducted in 60 centers throughout North America, Europe, and India. The study will also be investigating a secondary endpoint, the reduction of non-high-density lipoprotein cholesterol.
Recently, Omthera announced results of its ECLIPSE study (Epanova Compared to Lovaza in a Pharmacokinetic Single-Dose Evaluation), in which the company reportedly found Epanova to be dramatically more bioavailable compared to existing omega-3 prescription drug Lovaza. The company noted that plasma levels of EPA and DHA in subjects on a low-fat diet who received Epanova were more than four times higher than levels in those given Lovaza.
“Given its positive clinical profile demonstrated thus far, Epanova could offer physicians the option of prescribing a significantly lower dosage of drug to patients (2 g/day), with a more predictable absorption profile and the ability to titrate up, when needed, for further triglyceride lowering,” said Michael Davidson, MD, chief medical officer and cofounder of Omthera Pharmaceuticals.
“The results of Omthera’s Epanova studies thus far have been highly encouraging,” said John J.P. Kastelein, MD, PhD, one of the principal investigators for the EVOLVE study. Kastelein is professor of medicine and chairman of the department of vascular medicine at the Academic Medical Center at the University of Amsterdam.