Amarin reported positive topline results from a Phase III study evaluating its lead product AMR101 in patients with mixed lipidemia (two or more lipid disorders). The 12-week Anchor study showed that compared with placebo, both doses of AMR101 reduced triglyceride levels (the primary endpoint) without concurrently raising LDL-C levels (a secondary endpoint) in patients receiving background statin therapy. 73% of patients in the trial were diabetic, and the results were significant for both diabetic and nondiabetic participants. Amarin says the Anchor trial results support and build on data from the Phase III Marine study reported in November 2010. Marine evaluated AMR101 in patients with very high triglyceride levels (>500 mg/dL).
Specifically, the Anchor study demonstrated that the 4 g and 2 g daily doses of AMR101 led to statistically significant placebo-adjusted median reductions in triglyceride levels of 21.5% and 10.1%, respectively among mixed lipidemia patients on statin therapy. Moreover, the 4 g dose of AMR101 led to a 6.2% reduction in LDL-C levels from baseline, compared with placebo. The 2 g dose led to a 3.6% reduction in LDL-C. Non-HDL-C levels decreased 13.6% in the 4 g cohort, and by 5.5% in the 2 mg cohort. Statistically significant decreases in Apo B, Lp-PLA2 and VLDL-cholesterol were also observed.
“The Anchor trial results are even more remarkable than the broadly positive Marine trial results,” remarks Joseph S. Zakrezewski, Amarin CEO. “We believe these results clearly differentiate AMR101 from other triglyceride-lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population.”
AMR101 is a prescription-grade omega-3 fatty acid, which Amarin is developing as a prescription medicine for patients with very high triglyceride levels (> 500 mg/dL), and as what it claims is a potentially first-in-class treatment for patients with high triglyceride levels (200-500 mg/dL) who are also on statin therapy for raised LDL-cholesterol levels. The firm is separately planning to develop the product for preventing cardiovascular events.
Amarin expects to submit an NDA to FDA for approval of AMR101 as a treatment for very high triglycerides in the third quarter of 2011, based on the Marine study data. The firm said it may also decide to add the Anchor trial results to the NDA, depending on certain conditions including the timing of submission. In order to obtain a separate indication for AMR101 based on the Anchor trial results, FDA would require the firm to have a clinical outcomes study substantially under way at the time of NDA filing.