Amarin Appoints Medpace as CRO for two Phase 3 Cardiovascular Trials
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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.”
As previously announced, Amarin has secured agreements from the U.S. Food and Drug Administration (FDA) through the Special Protocol Assessment (SPA) process for both of the Phase 3 trials. The trials are expected to commence shortly, report top line data in 2011 with the New Drug Application (NDA) expected to be filed with the FDA not later than 2012.
The Phase 3 AMR101 MARINE Study will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels of =500 mg/dL.
The Phase 3 mixed dyslipidemia trial will be a multi-center, placebo-controlled, randomized, 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. This trial is aimed at potentially broadening the label for AMR101 to position it as “best-in-class” in the prescription Omega-3 market in the U.S as well as to show its potential as an effective combination therapy with established statin therapies.
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.”
As previously announced, Amarin has secured agreements from the U.S. Food and Drug Administration (FDA) through the Special Protocol Assessment (SPA) process for both of the Phase 3 trials. The trials are expected to commence shortly, report top line data in 2011 with the New Drug Application (NDA) expected to be filed with the FDA not later than 2012.
The Phase 3 AMR101 MARINE Study will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels of =500 mg/dL.
The Phase 3 mixed dyslipidemia trial will be a multi-center, placebo-controlled, randomized, 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. This trial is aimed at potentially broadening the label for AMR101 to position it as “best-in-class” in the prescription Omega-3 market in the U.S as well as to show its potential as an effective combination therapy with established statin therapies.
