Amarin Corporation has enrolled patients for two Phase III clinical trials to assess AMR101, the company’s lead product candidate for treating cardiovascular disease.
The MARINE and ANCHOR Phase III clinical trials are designed respectively to demonstrate that AMR101 lowers triglyceride levels in patients with very high triglycerides and high triglycerides in patients with mixed dyslipidemia being treated with statins.
AMR101 is an ultra-pure omega-3 form being developed with ethyl ester of eicosapentaenoic acid (ethyl-EPA), which has been proven to lower plasma triglycerides during numerous independent studies.
Amarin interim chief executive officer Declan Doogan said that the company achieved regulatory and ethical approvals required for these trials and began patient enrollment in fewer than three months following securing full funding in October 2009.
“We intend AMR101 to be a best-in-class agent with greater convenience, broader label and a superior lipid-lowering profile to its nearest competitor,” Doogan said.
Over 27 million people in the US are estimated to have elevated triglyceride levels, which are associated with the increased risk of developing coronary artery disease as well as other metabolic disorders such as diabetes and obesity.