Amarin Corp has been boosted by data which suggests that its late-stage prescription-grade omega-3 fatty acid drug has the potential to be a best-in-class product.
The Irish firm, which is listed on the Nasdaq, has announced top-line results from a Phase III study which demonstrate that AMR101 (ethyl icosapentate) significantly lowered very high triglyceride levels in patients, compared to placebo. In the 229-patient MARINE study, Amarin noted that after 12 weeks, patients who received a 4mg dose of AMR101 experienced a 33% reduction in triglyceride levels compared to placebo, while the 2mg dose saw a 20% fall.
In a secondary analysis, group of patients whose triglyceride levels were above 750 mg/dL, AMR101 reduced triglyceride levels by 45% compared to placebo at the 4mg dose. Importantly, the company noted that patients receiving the drug did not exhibit an increase in median low-density lipoprotein (LDL), or 'bad' cholesterol, compared with placebo at either dose.
Amarin said it is "the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C". There were also statistically significant reductions "in several important lipid markers, including Apo B, Lp-PLA2 (lipoprotein-phospholipase A2), VLDL-C and total cholesterol".
Amarin chief executive Joseph Zakrzewski said the MARINE study was conducted in a population representative of "millions of people with very high triglyceride levels, including more than 3.8 million in the USA alone. We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market".
The company will now submit a New Drug Application in 2011, a year ahead of schedule. If approved, it would compete with GlaxoSmithKline's Lovaza (omega-3-acid ethyl esters).