Amarin to file NDA a year earlier after positive MARINE trial
This article was originally published in Scrip
Executive Summary
Three years after Amarin Corp decided to explore the potential cardiovascular properties of its lead compound, AMR101, which it had been developing as Miraxion to treat Huntington's disease, the Irish company has unveiled positive, statistically significant top-line results from the 229-patient MARINE study, its first Phase III clinical trial in patients with very high triglyceride levels (500 mg/dL). This is a patient segment for which GSK's Lovaza is already approved. The study met the primary endpoint of percent change in triglyceride levels from baseline to week 12, for both 4g and 2g dose groups. While Amarin hopes to gain some purchase in the high triglycerides market, the compound is also in another Phase III study, ANCHOR, for treating people with much less elevated triglyceride levels, a much bigger patient group.