Research and Development
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health.
Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. We are currently conducting the first of its kind long-term, prospective cardiovascular outcomes study in high-risk patients on statin therapy, the REDUCE-IT study. The primary objective of this multi-center, randomized, double-blind, placebo-controlled study is to test the hypothesis that taking a pure, EPA-only omega-3 drug on top of existing statin therapy can provide a significant incremental reduction in cardiovascular events.
The efficacy and safety of Vascepa were studied in two Phase 3 clinical trials, the MARINE trial and the ANCHOR trial. Both studies were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). REDUCE-IT is also being conducted under a SPA.
The MARINE study: A Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week study that treated patients with severe (≥500 mg/dL) hypertriglyceridemia, more commonly known as very high triglycerides, or VHTG, with 229 patients enrolled. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. In November, 2010, Amarin reported top-line data for the MARINE trial which met its primary endpoints.
The MARINE trial demonstrated that Vascepa significantly lowered triglycerides without increasing LDL-C (non-significant decrease of -2%). In addition, MARINE demonstrated a statistically significant decrease in multiple other important lipid biomarkers including non-HDL-C, apolipoprotein B (apo B), lipoprotein-phospholipase A2 (Lp-PLA2), very low-density lipoprotein cholesterol (VLDL-C), Total Cholesterol (TC) and high-sensitivity C-reactive protein (hsCRP).
Vascepa® (icosapent ethyl) capsules, a therapy approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with VHTG, the severe (≥500 mg/dL) hypertriglyceridemia patient population studied in the MARINE trial, is now available by prescription.
In the MARINE study, the only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo. These data are based on a pooled analysis of two clinical studies (MARINE and ANCHOR) that included patients with triglycerides values of 200 to 2000 mg/dL.
For more information about the currently approved label for Vascepa see www.vascepa.com.
The results of the MARINE study were published online in the American Journal of Cardiology in June 2011 and are available electronically through PubMed (available at: http://triglyceridespanel.ajconline.org/Content/PDFs/3-Bays-Eicosapentaenoic.pdf). Copyright to this document is held by its publisher. This reference is provided for investors and is not a substitute for the approved label for Vascepa. Note that in publications about Vascepa (icosapent ethyl) its clinical name is AMR101.
The ANCHOR trial: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study in patients with high triglycerides (≥200 mg/dL and <500 mg/dL) who were also on statin therapy. 702 patients were enrolled in this trial. The primary endpoint in the trial was the percentage change in triglyceride level from baseline of Vascepa-treated subjects compared to placebo after 12 weeks of treatment. In April 2011, Amarin reported top-line results from the ANCHOR trial. The ANCHOR trial met its primary and secondary endpoints.
One of the ANCHOR trial's key secondary endpoints was to demonstrate a lack of elevation in LDL-C in order to avoid offset to the target of cholesterol lowering therapy. The trial's non-inferiority criterion for LDL-C was met at both Vascepa doses. For the 4 grams per day Vascepa group, LDL-C decreased significantly (-6.2%, P=0.0067) from baseline versus placebo, demonstrating superiority over placebo.
Other secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2) and very-low-density lipoprotein cholesterol (VLDL-C).
In this trial, the safety profile of Vascepa was comparable to placebo and there were no treatment-related serious adverse events. Vascepa does not have an FDA-approved indication for use in this patient population due to uncertainty on the connection between triglyceride reduction and cardiovascular risk reduction, but promotion of ANCHOR data is permitted to healthcare professionals under agreement with the FDA and the U.S. government.
The results of the ANCHOR study were published online in the American Journal of Cardiology in June 2011 and are available electronically through PubMed (available at: http://triglyceridespanel.ajconline.org/Content/PDFs/1-Ballantyne-Efficacy.pdf). Copyright to this document is held by its publisher. This reference is provided for investors and should not be construed as marketing Vascepa for this indication.
The REDUCE-IT (Reduction of Cardiovascular Events Outcomes trial): A prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of Vascepa as an add-on to statin therapy, in reducing the first major cardiovascular event in an high-risk patient population compared to statin therapy alone. Patients enrolled in the study have elevated triglyceride levels and at least one other defined cardiovascular risk factor. The control arm of the study is comprised of patients on optimized statin therapy. The active arm of the study is comprised of patients on optimized statin therapy plus Vascepa. Entry requirements for participants in this study include elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. This study is being conducted at over 400 clinical sites in 11 countries with the largest number of sites located within the United States.
REDUCE-IT was initiated in November 2011 and is now fully enrolled. The REDUCE-IT study is designed to be completed after reaching an aggregate number of cardiovascular events. Based on projected event rates, it is estimated that the REDUCE-IT study can be completed around the end of 2017 with results then expected to be available and published in 2018. A pre-specified efficacy and safety analysis is scheduled to be conducted by the independent data monitoring committee at approximately 80% of the total primary cardiovascular events targeted for completion of the study. Amarin anticipates that onset of 80% of the target events will be reached in the first half of 2017 and that the interim analysis will be conducted before the end of Q3 2017.
For more information, please visit http://www.clinicaltrial.gov/ct2/show/NCT01492361.
For more information on published studies related to Vascepa (icosapent ethyl) capsules, known in the scientific literature as AMR101, see Investor Relations - Publications.
This page was last updated on January 7, 2017.
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