Amarin Corporation plc (NASDAQ:AMRN) today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.
Dr. Doogan, Interim Chief Executive Officer of Amarin, commented “Following extensive due diligence on several global CROs, we selected Medpace based on their expertise in conducting cardiovascular and metabolic studies and their knowledge of the regulatory environment relevant to this program. We were also impressed by their international reach, an important requirement given that one of the Phase 3 trials with AMR101 will be conducted across a number of international regions including the U.S.”
Dr. David Orloff, Executive Director of Regulatory Affairs at Medpace, commented “We are pleased to be working with Amarin on the Phase 3 development of AMR101 for hypertriglyceridemia and mixed dyslipidemia. As many as 28 million people in the U.S. have elevated blood triglyceride levels, a major risk factor for cardiovascular morbidity and mortality. AMR101, an ultra-pure, prescription grade ethyl-EPA product, offers the potential to be a novel, safe and effective therapy for this condition.”