05.07.12
Omthera Pharmaceuticals, Inc., has announced positive top-line data from its EVOLVE clinical study for Epanova, the company's lead compound for the treatment of patients with very high triglycerides. The Phase 3 clinical trial randomized 399 subjects with triglyceride levels of 500-2000 mg/dl to 2, 3, or 4 grams of Epanova, or 4 grams of olive oil for a total of 12 weeks of treatment. The primary endpoint of the trial was the percentage change in triglyceride level from baseline to week 12, and the secondary endpoint was the reduction in non-HDL-cholesterol. The top-line results demonstrated highly statistically significant reduction of triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2 gram cohort and 31% for those subjects on the 4 gram dose. Furthermore, Epanova appeared safe and well tolerated, with discontinuation rates due to adverse events, primarily gastrointestinal, ranging from 5% to 7% across all dosing groups.