Epanova meets Phase III hypertriglyceridemia endpoints

Omthera Pharmaceuticals Inc. (Bedminster, N.J.) said once-daily 2 and 4 g doses Epanova as an add-on to statin therapy each met the primary endpoint of reducing non-HDL-C from baseline to week six vs. active control in the Phase III ESPIRIT trial to treat hypertriglyceridemia. Specifically, 2 g Epanova reduced non-HDL-C by 4% (p<0.05) and 4 g Epanova reduced non-HDL-C by 7% from baseline to week six vs. a 1% reduction for placebo (p<0.001). On secondary endpoints, low- and high-dose Epanova significantly reduced triglyceride levels from baseline to week six vs. active control (15% and 21%, respectively, vs. 6%, p<0.001 for both). Both doses of Epanova non-significantly increased HDL-C by 3% vs. 2% for active control. The double-blind, U.S. Phase III ESPRIT trial enrolled 647 patients with fasting triglyceride levels of 200-500 mg/dL. Olive oil was the active control.

Omthera also reported additional data from the Phase III EVOLVE trial showing that once-daily 2 and 4 g Epanova non-significantly increased mean HDL-C from baseline to week 12 vs. placebo (8% and 6%, respectively, vs. 2%). The company said low- and high-dose Epanova did significantly reduce several markers of atherogenicity, including apolipoprotein C-III ( APOCIII; APOC3) and lipoprotein-associated phospholipase A2 ( PLA2G7; PAFAH; Lp-PLA2), vs. placebo. In April, Omthera reported that all doses of once-daily Epanova -- 2, 3 and 4 g -- met the primary endpoint in EVOLVE of reducing mean triglyceride levels from baseline to week 12 vs. placebo. EVOLVE enrolled 399 patients with triglyceride levels of 500-2,000 mg/dL (see BioCentury Extra, April 26). ...