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 have a deep-rooted, consistent, and continuous scientific commitment to hypertriglyceridemic research. Our most important trial is REDUCE-IT, the first of its kind long-term, prospective cardiovascular outcomes study in high-risk patients on statin therapy. The primary endpoint of this double-blind, prospective, placebo-controlled study is to show that taking a pure, EPA-only omega-3 drug on top of existing statin therapy can provide a significant reduction in cardiovascular events.
REDUCE-IT was initiated in November 2011. As of February 2015, the 8,000 patient study had over 7,300 patients enrolled. Patient enrollment is expected to be completed within 2015. 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 in or about 2017 with results then expected to be available and published in 2018. The REDUCE-IT protocol includes a pre-specified interim analysis by an independent Data Monitoring Committee after approximately 60% of the planned event milestones have occurred. The interim review by the independent Data Monitoring Committee is expected to occur during 2016. REDUCE-IT is a global study, and is expected to enroll over 60% of its patients from western countries, ensuring that study results are applicable to the North American patient population.
For more information, please visit http://www.clinicaltrial.gov/ct2/show/NCT01492361
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).*
*based on pooled data across 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.
The FDA has not completed its review of the ANCHOR trial. Vascepa is not approved for use in this patient population.
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 multi-center, prospective, 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 (>150 mg/dL) 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.
In December 2011 Amarin announced that the first patient was dosed in the REDUCE-IT Study. REDUCE-IT is the first ever conducted prospective outcomes study in a Western population of the effect of lowering triglycerides in patients who despite statin therapy have above normal triglyceride levels.
In February 2015, Amarin announced that over 7,300 patients have been enrolled in REDUCE-IT. The study plan provides for enrollment of an aggregate of approximately 8,000 patients, which Amarin expects to be completed in 2015. The REDUCE-IT study will be completed after reaching an aggregate number of cardiovascular events. Based on current projections, Amarin estimates completing the REDUCE-IT study in or about 2017 with results expected to be available in 2018. Amarin estimates that mean and median baseline triglyceride levels for patients enrolled in this study will exceed 200 mg/dL.
For more information on published studies related to Vascepa (icosapent ethyl) capsules, known in the scientific literature as AMR101, see Investor Relations - Publications.
Investigator-initiated Trials and Grants
Amarin's scientific commitment includes providing grants to support research and education in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids, including the funding of an outcomes study. Amarin's website for the submission and management of Investigator Initiated Trials (IITs) is located at https://amariniit-public.steeprockinc.com.
This page was last updated on November 12, 2014.