Phase 3 study of AMR101 for the treatment of hypertriglyceridemia
Amarin announced positive results from its Phase 3 study of AMR101 for the treatment of very high triglyceride levels or hypertriglyceridemia. This study, known as the MARINE trial, was a multi-center, placebo-controlled, randomized, double-blind, study that enrolled 229 patients with fasting triglyceride levels that were ≥500 mg/dL. The study's primary endpoint, the percent change in triglyceride (TG) levels from baseline to week 12, was met for both the 4 gram and 2 gram dose groups. The MARINE study was required to meet a stringent level of statistical significance of 1% (p < 0.01), as agreed in the Company's SPA (Special Protocol Assessment) with the FDA. Twenty-five percent of patients were on background statin therapy. The patient group treated with 4 grams of AMR101 showed a significant median TG decrease of 33% (P < 0.0001) compared to placebo, and the patient group treated with 2 grams of AMR101 showed a significant median TG decrease of 20% (P = 0.0051) compared to placebo. The median baseline triglyceride levels were 703, 680 and 657mg/dL for the patient groups treated with placebo, 4 grams of AMR101 and 2 grams of AMR101, respectively.
In a subgroup of patients with baseline TG >750 mg/dL, the median decrease in TG levels from placebo was 45% for 4 grams and 33% for 2 grams, both statistically significant (P= 0.0001 for 4 grams and P= 0.0016 for 2 grams, respectively). The median baseline TG levels in this subgroup were 1052, 902 and 948mg/dL for placebo, 4 gram and 2 gram groups, respectively. In addition, the subgroup of patients on background statin therapy had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.
AMR101 did not result in an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). Furthermore, there was a statistically significant decrease in median non-HDL-C (total cholesterol less "good cholesterol") compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]). There were also statistically significant reductions in several important lipid markers, including Apo B, Lp-PLA2 (Lipoprotein-phospholipase A2), VLDL-C and Total Cholesterol.
Significant scientific and clinical evidence supports the efficacy of AMR101 (ethyl icosapentate or ethyl-EPA) in reducing triglyceride levels.
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