Amarin Corporation is expecting to complete enrolment in 2011 for two pivotal Phase 3 clinical trials for its lead drug candidate, AMR101, to treat elevated triglyceride levels.
Amarin initiated the trials, ANCHOR and MARINE, in early 2010 to evaluate the efficacy of AMR101 to treat elevated triglyceride levels in two patient populations.
Over 150 of the 650 patients have been targeted for the ANCHOR trial and 100 of the 240 patients have been targeted for the MARINE trial.
The trials received US FDA special protocol assessment agreement in 2009.
Amarin Corporation interim CEO Dr. Declan Doogan said the company believes AMR101 has the potential to be a best-in-class prescription omega-3 drug to treat patients with high triglycerides or high triglycerides with mixed dyslipidemia.
“Elevated triglycerides are increasingly being recognised as an important independent risk factor for cardiovascular disease,” Dr. Doogan said.
Amarin expects to file a new drug application in 2012.