News | January 11, 2010

Drug Tested to Lower Triglycerides in At-Risk Patients

January 11, 2010 – The first patients were enrolled in the phase 3 clinical trials for a drug designed to lower triglycerides for patients at risk for cardiovascular disease.

The MARINE and ANCHOR clinical trials are designed to demonstrate that the drug candidate AMR101 lowers triglyceride levels in patients with very high triglycerides (the MARINE Study) and high triglycerides in patients with mixed dyslipidemia being treated with statins (the ANCHOR Study). Enrollment in both trials should be completed in 2011.

AMR101 is an ultra-pure omega-3 form being developed with ethyl ester of eicosapentaenoic acid (ethyl-EPA). Numerous independent studies have demonstrated the safety, tolerability and efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. The single active ingredient (ethyl-EPA) formulation of AMR101 confers potential improvements against earlier-generation omega-3 products.

In the MARINE study, very high triglyceride levels are defined as levels greater than 500 mg/dL. In the ANCHOR study high triglyceride levels are defined as levels equal to or above 200 mg/dL and less than 500 mg/dL. Both of the phase 3 trials were granted special protocol assessment (SPA) agreements by the FDA and will run concurrently.

The MARINE Study (Study 16) is a multicenter, 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. The trial aims to recruit approximately 240 patients from clinical sites in multiple countries (United States, Denmark, Finland, Germany, India, Mexico, The Netherlands, Russia, South Africa, Ukraine and Italy). The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period. Results from the extension period are not required for regulatory approval.

The ANCHOR Study (Study 17) is a multicenter, 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 high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. The trial aims to recruit approximately 650 patients into clinical sites in the United States. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.

No prescription omega-3 based drug is currently approved in the U.S. for patients with high triglyceride levels in mixed dyslipidemia being treated on statins.

For more information: www.amarincorp.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init