Amarin, a clinical-stage biopharmaceutical company focused on the treatment of cardiovascular disease, today announced that the first patients have been enrolled in the MARINE and ANCHOR Phase III clinical trials for AMR101, Amarin’s lead product candidate. These clinical trials are designed to demonstrate that 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). It is estimated that more than 27 million people in the US have elevated triglyceride levels, which are associated with the increased risk of developing coronary artery disease and are a component of certain other metabolic disorders, such as diabetes and obesity.
AMR101 is an omega-3 form being developed with ethyl ester of eicosapentaenoic acid (ethyl-EPA). Numerous independent studies have demonstrated that ethyl-EPA can lower plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. The single active ingredient (ethyl-EPA) formulation of AMR101 might offer an improvement over 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 but less than 500 mg/dL. Both of the Phase III trials were granted Special Protocol Assessment (SPA) agreements by the FDA and will run concurrently.
‘We are pleased that both of these Phase III trials have commenced enrollment,’ stated Dr Declan Doogan, Interim CEO. ‘We achieved regulatory and ethical approvals required for these trials and commenced patient enrollment in less than three months following our securing full funding for these trials in October 2009. The fast pace at which these trials have commenced is a tribute to all the people involved and the enthusiasm experts have in the safety and efficacy profile of AMR101.’
The MARINE Study (Study 16) is a multi-center, 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 (USA, 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. After 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 multi-center, 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 US for patients with high triglyceride levels in mixed dyslipidemia being treated on statins. Amarin believes that the results of this trial could lead to approval of AMR101 for a substantially larger market opportunity than is currently approved for similar prescription drugs.
Upon enrollment in these Phase III trials, patients will undergo a six- to eight-week washout period before randomization to the 12-week treatment period. Enrollment in both trials is anticipated to be completed in 2011.