Amarin’s Amr101 Pivotal Phase 3 Marine Clinical Trial Completes Patient Enrollment and Randomization
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Amarin Corporation plc announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.
According to the company, the MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dl. Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines.
The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The MARINE study is the largest controlled therapeutic trial ever conducted in this population.
As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. Consistent with previous guidance, the Company anticipates completing patient enrollment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011.
This trial is designed to evaluate the safety and efficacy of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (between 200 mg/dl and 500 mg/dl) who are also on statin therapy for elevated LDL cholesterol levels. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for this indication.
Dr. Declan Doogan, Amarin’s Interim CEO, said: “We are extremely pleased that the MARINE study has been able to complete recruitment faster than we initially expected and we very much look forward to reviewing and reporting the results of this trial early in 2011.” He added, “Elevated triglyceride levels are increasingly being recognized and treated as an independent modifiable risk factor for cardiovascular disease in much the same way as elevated LDL cholesterol levels were more than a decade ago. We believe that AMR101 represents an improved treatment alternative for patients with higher than normal triglyceride levels.”
According to the company, the MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dl. Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines.
The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The MARINE study is the largest controlled therapeutic trial ever conducted in this population.
As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. Consistent with previous guidance, the Company anticipates completing patient enrollment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011.
This trial is designed to evaluate the safety and efficacy of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (between 200 mg/dl and 500 mg/dl) who are also on statin therapy for elevated LDL cholesterol levels. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for this indication.
Dr. Declan Doogan, Amarin’s Interim CEO, said: “We are extremely pleased that the MARINE study has been able to complete recruitment faster than we initially expected and we very much look forward to reviewing and reporting the results of this trial early in 2011.” He added, “Elevated triglyceride levels are increasingly being recognized and treated as an independent modifiable risk factor for cardiovascular disease in much the same way as elevated LDL cholesterol levels were more than a decade ago. We believe that AMR101 represents an improved treatment alternative for patients with higher than normal triglyceride levels.”
