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news.Amarin has said that first patients were enrolled in the Marine and Anchor phase 3 clinical trials for AMR101. 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).
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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, consistent with current medical treatment guidelines, very high triglyceride levels are defined as levels greater than 500mg/dl. In the Anchor study, also consistent with current medical treatment guidelines, high triglyceride levels are defined as levels equal to or above 200mg/dl and less than 500mg/dl. Both of the phase 3 trials were granted Special Protocol Assessment (SPA) agreements by the FDA and will run concurrently.
Declan Doogan, interim chief executive officer of Amarin, said: “We are pleased that both of these Phase 3 trials have commenced enrollment. 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.
“This represents another key step forward in our recently repositioned strategy to focus on cardiovascular drug development. We intend AMR101 to be a best-in-class agent with greater convenience, broader label and a superior lipid.”