Amarin's Phase 3 ANCHOR Study Results Presented at American Heart Association's Scientific Sessions 2011
BEDMINSTER, N.J., and DUBLIN, Ireland, Nov. 16, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, announced today the first presentation in a scientific session of data from Amarin's Phase 3 clinical trial, the ANCHOR study, in which patients with high triglycerides who were also on statin therapy experienced a significant reduction in triglyceride levels and other lipid parameters, as well as important inflammatory biomarkers. The data, from Amarin's ANCHOR Phase 3 pivotal trial, were presented
by Christie M. Ballantyne, M.D., at the American Heart Association's Scientific Sessions 2011.
As reported in April 2011, the ANCHOR trial met its primary endpoint, which was defined as themedian placebo-adjusted percentage change in triglyceride levels from baseline after 12 weeks of treatment. This endpoint was achieved at doses of 4 grams and 2 grams per day with median placebo-adjusted reductions in triglyceride levels of 21.5% (P<0.0001 value) for 4 grams and 10.1% (P=0.0005) for 2 grams. The median baseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of AMR101 per day, respectively. The analysis of subgroups by baseline triglyceride tertiles showed that higher baseline triglycerides resulted in greater triglyceride reductions.
Secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2). The 4 gram dose was associated with statistically significant reductions in non-HDL-C (13.6%), LDL-C (6.2%), apo B (9.3%), Lp-PLA2 (19%) and high-sensitivity C-reactive protein (hsCRP )(22%) at week 12 compared to placebo. The 2 gram dose was associated with statistically significant reductions in non-HDL-C (5.5%), apo B (3.8%), Lp-PLA2 (8.0%) and a non-statistically significant reduction in LDL-C (3.6%) and high-sensitivity C-reactive protein (hsCRP) (6.8%) at week 12 compared to placebo.
Importantly, neither the 2 gram or 4 gram dose showed any significant increase in LDL-C compared to placebo; this was a pre-specified endpoint in this study using a non-inferiority test and, at the 4 gram dose, demonstrated not only non-inferiority but a statistically significant 6.2% reduction for patients who were optimally treated with atorvastatin, simvastatin, or rosuvastatin.
In the trial, AMR101 appeared to be safe and well tolerated, with incidence of treatment-emergent adverse events similar to placebo. No significant changes in fasting blood glucose, hemoglobin A1C, vital signs, electrocardiograms, or liver or kidney function with either AMR101 dose.
"The positive data from the ANCHOR study show that AMR101 may be an important therapeutic option for mixed dyslipidemia patients with persistent high triglyceride levels on statin-therapy," said Dr. Ballantyne. "One of the potential explanations for the continued elevation of cardiovascular risk in patients with persistent high triglyceride elevations despite statin therapy may be due to increased inflammation. Patients in the ANCHOR study who received AMR101 at 4 grams/day experienced a significant reduction in median placebo-adjusted inflammation biomarkers, specifically hsCRP and Lp-PLA2. The REDUCE-IT cardiovascular outcomes study will investigate the extent to which lipid and other biomarker changes observed by AMR101 will translate into a reduction in cardiovascular events."
The ANCHOR trial was a Phase 3, multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study. 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 was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing for the treatment of patients with very high triglyceride levels (≥500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (≥200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP. AMR101 demonstrated a safety profile comparable to placebo in two completed Phase 3 clinical
Amarin Corporation plc is a late-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [≥500 mg/dL]), as reported in November 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [≥200 and <500mg/dL] with mixed dyslipidemia), as reported in April 2011. Both the MARINE and ANCHOR trials were conducted under Special Protocol
Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. In September 2011, Amarin submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AMR101 for treatment of the patient population studied in the MARINE trial. Amarin plans to separately seek approval for the population studied in the ANCHOR trial after its REDUCE-IT cardiovascular outcomes trial is substantially underway. In August 2011, an SPA agreement with the FDA was reached for the REDUCE-IT cardiovascular outcomes
study. The Company seeks to have this study substantially underway before the end of 2012.
This press release contains forward-looking statements, including statements about the efficacy, safety and therapeutic benefits of the Company's product candidates, clinical trial results, including statements about the clinical importance of certain biomarkers and the impact of AMR101 on such biomarkers. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations and the planned cardiovascular outcomes study; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; risks associated with qualifying new contract manufacturers prior to
commercial launch; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our patent applications may not issue; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K
and its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. The Company's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as marketing the use of such product candidates.
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Source: Amarin Corporation plc
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