Amarin up on encouraging Vascepa data in COVID-19, cardiovascular events

 

• Amarin (NASDAQ:AMRN) rises 7% after announcing VASCEPA (icosapent ethyl)-related scientific findings during the NLA Scientific Sessions 2020, held from December 10 – 12, 2020.
• Following administration of VASCEPA, a unique prescription eicosapentaenoic acid (EPA)-based therapy at 4 g/day in the successful REDUCE-IT cardiovascular outcomes study, analysis shows that median serum EPA levels increased in year 1 to well over 100 ug/mL (144 μg/mL; p=1x10^-30) and increased ~400% across the study from baseline (26.1 μg/mL) versus placebo. Docosahexaenoic acid levels were measured and showed a decrease of 2.9% (p=0.002).
• On-treatment EPA levels in the VASCEPA group were strongly associated with reduced cardiovascular events, including benefits observed in the primary and key secondary endpoints.
• The VASCEPA COVID-19 CardioLink-9 Trial enrolled 100 SARS-CoV-2 positive and symptomatic outpatients. 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).
• Additionally, 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.
• These results have not yet been published or reviewed by regulatory authorities. Additional study is needed.
• VASCEPA COVID-19 CardioLink-9 trial is the first in a series of ongoing 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 and A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) sponsored by Kaiser Permanente.
• Other Amarin-supported abstracts on REDUCE-IT study and providing mechanism of action insights were also presented.
• The company will host a webcast today at 8:00 a.m. EST to further discuss these and other VASCEPA-related findings.
• https://seekingalpha.com/news/3643938-amarin-up-7-on-encouraging-vascepa-data-in-covidminus-19-and-cardiovascular-events