Amarin Reports Encouraging Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with VASCEPA® (Icosapent Ethyl) in Late Breaker Presentation at National Lipid Association (NLA) Scientific Sessions 2020
December 12, 2020 at 21:30 PM EST
VASCEPA COVID-19 CardioLink-9 Randomized Trial suggests improvement in patient-reported COVID-19 symptoms while achieving its primary endpoint by demonstrating a 25% reduction in high-sensitivity C-reactive protein (hsCRP) with encouraging short-term safety and tolerability data using VASCEPA loading dose
VASCEPA administration resulted in a significant 52% reduction of the total patient-reported symptom outcome prevalence score as compared to a 24% reduction in the usual care group
Larger follow-on clinical studies have commenced of VASCEPA as a therapeutic option in COVID-19 settings, anticipated to be completed in 2021
Amarin to Webcast Discussion of Presented Data on Monday, December 14, 2020 at 8:00 a.m., Eastern Standard Time
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 12, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced the presentation of clinical results from the CardioLink-9 Trial, the first results of a study of VASCEPA® (icosapent ethyl) in COVID-19 infected outpatients. The presentation, “First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial”, was made virtually as a Late Breaker at the National Lipid Association (NLA) Scientific Sessions 2020, and was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.
“In the current environment, most COVID-19 positive patients remain outside of the clinical setting, following the advice of their doctor to stay home and quarantine unless absolutely necessary to enter the hospital,” commented Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and co-principal investigator of COVID-19 CardioLink-9 and the encouraging results of this pilot study. “The large and significant improvement in patient-reported symptoms may provide a safe, well-tolerated, and relatively inexpensive option to impact upon COVID-19-related morbidity. The reduction in markers of inflammation with icosapent ethyl is also important given what we know about the pathobiology of COVID-19.”
The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2 positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, myalgia. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Baseline characteristics were comparable between groups.
The primary biomarker endpoint of the study was within-group changes in high-sensitivity C-reactive protein (hsCRP), a measure of inflammation. Within-group changes in D-dimer were also examined. VASCEPA administration resulted in a 25% reduction in hsCRP (p=0.011) as well as a reduction in D-dimer (p=0.048).
In addition to these biomarker changes, assessment was made of COVID-19 symptom changes from baseline to 14 days in the influenza patient-reported outcome (FLU-PRO) score, a validated patient-reported outcome measure designed to evaluate the presence, severity and duration of flu symptoms in clinical trials. VASCEPA administration resulted in a significant 52% reduction of the total FLU-PRO prevalence score as compared to a 24% reduction in the usual care group (p=0.003 between groups), with reductions across individual score domains, including a significantly larger reduction compared to usual care in the body/systemic domain (54% vs. 26%; p=0.003). Significant reductions in the FLU-PRO symptom score compared to usual care were also observed in the total symptom score (p=0.003), as well as in the body/systemic (p=0.0007) and chest/respiratory (p=0.01) domains.
VASCEPA CardioLink-9 Study is an investigator-initiated study supported by Amarin and by HLS Therapeutics, Inc. The principal investigators of the study were Subodh Verma, M.D., Ph.D., FRCSC, Professor and Cardiac Surgeon at University of Toronto and Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School.
Limitations of this study include the modest sample size, the unblinded nature of this randomized trial, and that the trial was not powered for clinical events. These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.
This randomized trial represents the first human experience with an 8 g/day loading dose of icosapent ethyl and has suggested short-term safety and tolerability in a modest sample size. Regarding COVID-19, this study provides the first evidence of potential early anti-inflammatory effect of icosapent ethyl in symptomatic, COVID-19 positive outpatients.
Amarin added that the VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing investigator-sponsored studies into the potential role of VASCEPA therapy in COVID-19 settings. Other ongoing trials include PREPARE-IT: Prevention of COVID19 With EPA in Healthcare Providers at Risk - Intervention Trial sponsored by Estudios Clínicos Latino América, and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.
This presentation of CardioLink-9 study results was one of multiple data presentations at the NLA Scientific Sessions supported by Amarin. Additional information on NLA Scientific Sessions 2020 can be found here.
Audio Webcast Information
Scientific Rationale for Study of VASCEPA in COVID-19 Patients
The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:
Ongoing preclinical and clinical research may provide further insights into the scientific and clinical understanding of these hypothetical effects of VASCEPA in COVID-19 disease mitigation. Whereas vaccines are intended to help eradicate the virus from proliferating, other therapeutics under development and clinical testing such as antibodies or other medicines may play roles in the treatment of patients in various settings across the infection and recovery continuum.
For more information on studies of VASCEPA in COVID-19 patients, see the frequently asked question entry on Amarin’s corporate website, here.
About Cardiovascular Risk
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.14 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.15,16,17
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.18 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.19 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.20 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Indications and Limitation of Use
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with
Availability of Other Information About Amarin
Amarin Contact Information
1 Cummings MJ, Baldwin MR, Abrams D, et al. Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study. Lancet. 2020; (published online May 19.) https://doi.org/10.1016/S0140-6736(20)31189-2