Amarin Corp Plc (AMRN)

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VASCEPA(R) (Icosapent Ethyl) Reported to Impact Vulnerable Coronary Plaque Features in New Analyses of EVAPORATE Study Presented as Late-Breaking Science at ESC Preventive Cardiology 2021
2021-04-17 09:50:00 AM ET (GlobeNewswire)
   
   
Study quantified coronary plaque changes in patients administered 4 g/day of VASCEPA(R) (icosapent ethyl) on top of statin therapy

Effect on coronary plaque stabilization reported to be significant at 9 months and sustained at 18 months

Amarin Corporation plc (NASDAQ:AMRN) today announced that further analyses from the Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: EVAPORATE Trial were presented as Late-Breaking Science at European Society of Cardiology (ESC) Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17, 2021, 3:50 PM CEST (Central European Summer Time) by Andrew Buckler, Founder and CTO of Elucid. As previously reported and published in the European Heart Journal, VASCEPA(R) (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. The Effect of Icosapent Ethyl on Changes in Coronary Plaque Morphology: EVAPORATE analyses presented at ESC Preventive Cardiology 2021 demonstrated that with administration of 4 g/day of VASCEPA on top of statin t herapy, there was an observed change in plaque stability occurring at 9 months and sustained through 18 months.

"The EVAPORATE plaque morphology study provides valuable insight into how we can utilize scientific imaging to examine the mechanisms at work that may contribute to observed clinical trial results," commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. "The results suggest consistent benefits of icosapent ethyl on clinical cardiovascular outcomes as observed in the REDUCE-IT(R) cardiovascular outcomes study, and on plaque progression and plaque vulnerability as observed in EVAPORATE."

Of the 80 patients that were enrolled in the randomized, double-blind, placebo-controlled EVAPORATE trial, 55 patients had images that were able to be utilized for the histology-validated software. The EVAPORATE plaque morphology study used ElucidVivo (Elucid, Boston, MA), the first FDA-cleared analysis for specific tissue characterization using histopathologic correlates to assess plaque morphology characteristics, including Lipid Rich Necrotic Core (LRNC), fibrous cap thickness, and intraplaque hemorrhage (IPH). Whereas with placebo LRNC increased and cap thickness decreased, both indicative of moving to a less stable phenotype, with icosapent ethyl there was a measured LRNC decrease and cap thickness increase, indicative of moving to a more stable phenotype.

"Coronary plaque stabilization is an important finding with VASCEPA and may explain, in part, the substantial cardiovascular benefit seen in REDUCE-IT," said Craig Granowitz, M.D., Ph.D., Amarin's senior vice president and chief medical officer. "The EVAPORATE plaque morphology study results provide additional insight into one of the likely multifactorial effects of VASCEPA, which effects collectively have been shown or observed to lower residual cardiovascular risk."

The primary limitation of this single coronary plaque study as identified by its investigators is its small sample size. More study is needed to more fully understand the effects of VASCEPA on coronary plaque to determine the relationship, if any, of such plaque effects on cardiovascular risk reduction.

More information on ESC Preventive Cardiology 2021 can be found here.

About Amarin

Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, and Zug in Switzerland as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.