Phase 3 Study of AMR101 for Hypertriglyceridemia
Amarin Corporation announced positive results from its Phase 3 study of AMR101 for the treatment of patients with high triglycerides (TG) without increasing LDL-C levels in patients on background statin therapy. The ANCHOR trial, a multicenter, placebo-controlled, randomized, double-blind, 12-week pivotal study, enrolled 702 patients with fasting TG levels from 200mg/dL to <500mg/dL. The study evaluated the safety and efficacy of 2 grams and 4 grams of AMR101 with a primary endpoint defined as the percentage change in TG levels from baseline compared to placebo after 12 weeks of treatment. The key secondary endpoint was to demonstrate a lack of elevation of LDL-C in order to avoid offset to the primary target of cholesterol-lowering therapy.
At the end of 12-weeks, the ANCHOR study met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses. TG levels decreased 21.5% (P<0.0001) and 10.1% (P=0.0005) from baseline vs. placebo at 4 gram and 2 gram doses, respectively, both statistically significant. As for the secondary endpoints, LDL-C decreased significantly by 6.2% from baseline vs. placebo for the 4 grams per day group, demonstrating superiority over placebo (P=0.0067) and a decrease by 3.6% from baseline vs. placebo (P=0.0867) for the 2 grams per day group.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing TG levels.
For more information call (866) 960-7367 or visit www.amarincorp.com.