Amarin Corporation plc (NASDAQ: AMRN) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase 3 clinical trial of AMR101 (ethyl-EPA) in patients with mixed dyslipidemia. Renowned cardiologist and leading expert on dyslipidemia, Dr. Christie Ballantyne, Director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, will be the Principal Investigator for this Phase 3 trial.
This is the second SPA agreement received by Amarin for AMR101 in cardiovascular disease and follows the SPA agreement obtained in May 2009 in relation to the planned registration trial with AMR101 in patients with very high triglycerides (the AMR101 MARINE study). The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase 3 trial.
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented "Receiving FDA agreement on this Phase 3 trial in mixed dyslipidemia is an important endorsement of our strategy which aims to provide a more comprehensive label for AMR101. We plan to commence both this mixed dyslipidemia trial and the MARINE study in the third quarter of 2009, pending completion of the Company's longer term funding, as described in our press release earlier this week."
Commenting on the upcoming trial, Dr. Christie Ballantyne, Principal Investigator said "I am pleased to be working with Amarin on this trial. There is a very large population of patients with mixed dyslipidemia and elevated triglycerides for whom statins alone are insufficient therapy. AMR101, as an ultra-pure prescription-grade Omega-3 therapy, is particularly promising for combination therapy with statins given the strong safety, tolerability, and efficacy profile of EPA in reducing triglycerides."
The Phase 3 mixed dyslipidemia trial will be a multi-centre, placebo-controlled, randomised, double-blind, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels of ≥200 mg/dL and <500 mg/dL who are on statin therapy. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.
This trial is expected to enrol approximately 650 patients and will be conducted in centers throughout the United States. The Company plans to use the results of this Phase 3 trial as the basis for potentially broadening the label for AMR101 beyond treatment for very high triglycerides to include treatment for high triglycerides, the two patient groups that need hypotriglyceridemic therapy the most, as classified by the National Cholesterol Education Program (NCEP) Expert Panel (Adult Treatment Panel III, ATP III, 2002).