MYSTIC, Conn. and DUBLIN, April 18, 2011 /PRNewswire/ — Amarin
Corporation plc (Nasdaq:
AMRN), a clinical-stage biopharmaceutical company with a focus
on cardiovascular disease, today reported positive, statistically
significant top-line results from its ANCHOR trial for the
Company’s lead product candidate, AMR101. The Phase 3 trial met its
primary and secondary efficacy endpoints for both the 4 gram and 2
gram daily doses.
The purpose of the ANCHOR trial was to demonstrate that AMR101
is effective in reducing triglyceride levels in patients with high
triglycerides without increasing LDL-C (“bad cholesterol”) levels
in patients on background statin therapy. The ANCHOR trial
investigated AMR101 as a treatment for high triglycerides (≥200
and <500mg/dL) in 702 patients with mixed dyslipidemia (two or
more lipid disorders) on background statin therapy at LDL-C
(low-density lipoprotein cholesterol) goal who were at high risk of
cardiovascular disease. The majority of these patients were
diabetic (73%). This is the largest trial with omega-3 therapy
conducted in this important patient population. All patients were
on background statin therapy with simvastatin, atorvastatin or
rosuvastatin. Despite the benefits of statin therapy, patients in
this population have significant residual risk for cardiovascular
events. The trial’s primary endpoint was defined as the percentage
change in triglyceride levels from baseline compared to placebo
after twelve weeks of treatment. In addition, the study was powered
to demonstrate a lack of LDL-C elevating effect with AMR101
compared to placebo. The trial was conducted under a Special
Protocol Assessment (SPA) agreement with the FDA.
Triglyceride Reduction Levels Exceeded Company
Expectations
The primary endpoint for triglyceride change was achieved at
both 4 grams and 2 grams per day with median placebo-adjusted
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