Amarin Corporation plc (NASDAQ:AMRN) has presented clinical results from the CardioLink-9 Trial, the initial VASCEPA® study data in COVID-19 infected outpatients at the 2020 National Lipid Association Scientific conference.
Amarin presents COVID-19 CardioLink9 trial results
Deepak L. Bhatt made the presentation titled, “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.” Principal COVID-19 CardioLink 9 study investigator, Subodh Verma said that given the current circumstances, the majority of COVID-19 patients are outside clinical setup and they follow advice to quarantine and stay at home unless it’s necessary for a hospital visit. Verma explained that the large and significant patient symptoms improvements could offer a safe, well-tolerated, and inexpensive alternative impacting against COVID-19-related morbidity.
The COVID-19 CardioLink-9 Trail was an open-label, randomized study that enrolled SARS-CoV-2 positive and symptomatic individuals having cough, fevers, sore throat, myalgia, and shortness of breath. The VASCEPA arm patients received a loading dose of 8g per day for three days followed by 4g per day for 11 days in addition to usual care. The placebo group received usual care and baseline characteristics were comparable between the groups.
The study’s primary endpoint was a measure of an inflammation within-group in high sensitivity C-reactive protein changes. The study also examined within-group changes in D-dime. Interestingly, VASCEPA uses resulted in a 25% reduction in hsCRP and D-dimer. Besides these biomarker changes, there was an assessment of COVID-19 symptoms from baseline to day 14 in the influenza patient-reported outcome score.
Amarin reports VASCEPA findings and 2020 NLA
The company also presented VASCEPA® findings at the 2020 NLA Scientific session. The company’s SPV R&D and Chief Scientific Officer, Steven Ketchum said that they are delighted to have supported various presentations at the 2020 NLA which included two late Breakers. Ketchum said that they have continued to forge ahead with scientific driven evidence of VASCEPA’s uniqueness in cardiovascular risk reduction while offering support to investigators to explore ways VASCEPA can improve public health and lower costs of patient care.