Omega-3 phospholipids: Phase II data
Top-line data from the double-blind, Canadian Phase II TRIFECTA trial in 365 evaluable patients with mild to severe hypertriglyceridemia showed that once-daily 1 and 2 g CaPre each met the primary endpoint of reducing mean triglyceride levels from baseline to week 12 vs. placebo (placebo-adjusted reductions of 36.4% and 38.6%, respectively, p<0.001 for both). Acasti said the trial was not designed to show significance on any lipid other than triglycerides, but high-dose CaPre led to a 5.3% reduction in non-HDL-C from baseline to week 12 vs. placebo (p=0.038). Both doses of CaPre led to slight increases in HDL-C and high-dose CaPre led to a reduction in LDL-C. Furthermore, low- and high-dose CaPre led to mean placebo-adjusted reductions in very low-density lipoprotein (VLDL)-C of 10.9% and 13.5%, respectively. CaPre was well tolerated with no treatment-related serious adverse events reported. Full data from TRIFECTA are expected by year end. At that time, the company plans to finalize its next steps for CaPre, including a Phase III trial, with FDA. ...