Amarin (AMRN) Reports New Positive Data from ANCHOR
Tweet
Share
E-mailGet Alerts AMRN Hot Sheet
Join SI Premium – FREE
Amarin Corporation plc (Nasdaq: AMRN), 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.
From the release:
"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."
From the release:
"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."
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- JPMorgan Reinstates Amarin Corporation (AMRN) at Underweight
- Cytek faces $56M damages award in Beckman Coulter patent case
- FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris
Create E-mail Alert Related Categories
Corporate News, FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
