January 11, 2010 – The first patients were enrolled in the phase 3 clinical trials for a drug designed to lower triglycerides for patients at risk for cardiovascular disease.
The MARINE and ANCHOR clinical trials are designed to demonstrate that the drug candidate AMR101 lowers triglyceride levels in patients with very high triglycerides (the MARINE Study) and high triglycerides in patients with mixed dyslipidemia being treated with statins (the ANCHOR Study). Enrollment in both trials should be completed in 2011.
AMR101 is an ultra-pure omega-3 form being developed with ethyl ester of eicosapentaenoic acid (ethyl-EPA). Numerous independent studies have demonstrated the safety, tolerability and efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. The single active ingredient (ethyl-EPA) formulation of AMR101 confers potential improvements against earlier-generation omega-3 products.
In the MARINE study, very high triglyceride levels are defined as levels greater than 500 mg/dL. In the ANCHOR study high triglyceride levels are defined as levels equal to or above 200 mg/dL and less than 500 mg/dL. Both of the phase 3 trials were granted special protocol assessment (SPA) agreements by the FDA and will run concurrently.
The MARINE Study (Study 16) is a multicenter, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL. The trial aims to recruit approximately 240 patients from clinical sites in multiple countries (United States, Denmark, Finland, Germany, India, Mexico, The Netherlands, Russia, South Africa, Ukraine and Italy). The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period. Results from the extension period are not required for regulatory approval.
The ANCHOR Study (Study 17) is a multicenter, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. The trial aims to recruit approximately 650 patients into clinical sites in the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.
No prescription omega-3 based drug is currently approved in the U.S. for patients with high triglyceride levels in mixed dyslipidemia being treated on statins.
For more information: www.amarincorp.com