Amarin says data from the first Phase III trial evaluating its triglyceride-lowering drug AMR101 (ethyl icosapentate, or ethyl-EPA) has shown that the treatment leads to significant reductions in triglyceride levels without causing parallel rises in LDL-C levels. The firm has, as a result, brought forward its projected NDA filing for the drug to 2011; it had previously expected to file for approval of AMR101 during 2012. A separate ongoing Phase III AMR101 study, Anchor, expects to enrol 650 statin-treated patients with triglyceride levels of 200–500 mg/dL and mixed dyslipidemia. Topline results from Anchor are expected during mid-2011.
The Marine study evaluated AMR101 in 229 patients with very high triglyceride levels (500 mg/dL or above). Results showed the trial met its primary endpoint in terms of percentage change in triglyceride levels from baseline at 12 weeks for both AMR101 doses evaluated. Patients receiving the 4 g AMR101 dose demonstrated a median triglyceride decrease of 33% compared with placebo therapy. Those receiving the 2 g AMR101 dose still achieved an average reduction in triglyceride levels of 20%. Amarin says 25% of patients were on background statin treatment.
The Marine trial in addition showed that neither dose of AMR101 led to a concomitant increase in median LDC-C levels. Amarin claims the drug is therefore the only triglyceride-lowering therapy to be investigated in this patient population that doesn’t lead to rises in LDL-C. Conversely, AMR101 therapy did result in statistically significant, 8–18% decreases in median non-HDL-C. There were also statistically significant reductions in a number of lipid markers, including ApoB, Lp-PLA2, VLDL-C, and total cholesterol. The safety and tolerability of AMR101 was comparable to that of placebo.
“We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class on the market,” states Joseph S. Zakrzewski, Amarin executive chairman and CEO. “The Marine study was conducted in a population representative of millions of people with very high triclyceride levels, including more than 3.8 million in the U.S. alone. The Marine study results are encouraging, especially the positive outcomes with respect to LDL-C and other lipids, as we await the results of the ongoing Anchor study. While the market for a drug labeled for treatment of triglycerides of 500 mg/dL is already proven to be a billion dollar market, there are ten times the number of patients with triglycerides of 200–500m g/dL.”
Amarin is headquartered in Dublin, Ireland, and has its R&D headquartered in Mystic, Connecticut. The firm aims to partner the commercialization of AMR101 for hypertriglyceridemia and related cardiovascular diseases worldwide.