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

News | Cardiovascular Clinical Studies

Nov. 18, 2024 — Silence Therapeutics presented end-of-treatment data from its Phase 2 ALPACAR-360 study of zerlasiran, a ...

Home November 18, 2024
Home
News | Cardiovascular Clinical Studies

Aug. 15, 2024 — According to a new study being presented at ACC Asia 2024 in Delhi, India, drinking over 400 mg of ...

Home August 14, 2024
Home
Videos | Cardiovascular Clinical Studies

As part of DAIC's continuing Thought Leadership Series, this month Editorial Director Melinda Taschetta-Millane sits ...

Home July 30, 2024
Home
News | Cardiovascular Clinical Studies

July 25, 2024 — BioCardia, Inc., a global leader in cellular and cell-derived therapeutics for the treatment of ...

Home July 25, 2024
Home
News | Cardiovascular Clinical Studies

July 18, 2024 — Elucid, a pioneering AI medical technology company providing physicians with imaging analysis software ...

Home July 18, 2024
Home
News | Cardiovascular Clinical Studies

July 10, 2024 — CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and ...

Home July 10, 2024
Home
News | Cardiovascular Clinical Studies

July 9, 2024 — Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY ...

Home July 09, 2024
Home
News | Cardiovascular Clinical Studies

June 26, 2024 — Semaglutide, a medication initially developed for type 2 diabetes and obesity, significantly improves ...

Home June 26, 2024
Home
News | Cardiovascular Clinical Studies

June 21, 2024 — Lexicon Pharmaceuticals, Inc. announced that the peer-reviewed Journal of the American College of ...

Home June 21, 2024
Home
News | Cardiovascular Clinical Studies

June 20, 2024 — Microbot Medical Inc. announced its agreement with Brigham and Women’s Hospital (BWH), a leading ...

Home June 20, 2024
Home
Subscribe Now