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ARTICLE | Clinical News

SAR236553: Additional Phase II data

June 18, 2012 7:00 AM UTC

Additional data from the double-blind, placebo-controlled, international Phase II Study 1003 trial in 77 patients with heFH showed that subcutaneous REGN727 as adjunct to lipid lowering therapy produced significant reductions in mean LDL-C from baseline to week 12 of 28.9% for the 150 mg once-monthly dose (p=0.0113); 31.54% for the 200 mg once-monthly dose (p=0.0035); 42.53% for the 300 mg once-monthly dose (p<0.0001); and 67.9% for the 150 mg twice-monthly dose (p<0.0001) vs. 10.65% for lipid lowering therapy alone. Additionally, 150 mg twice-monthly REGN727 reduced LDL-C levels to <100 mg/dL in 93.8% of patients and to <70 mg/dL in 81.3% of patients vs. 13.3% and 0% for lipid lowering therapy alone. The trial enrolled patients with elevated LDL-C (>=100 mg/dL) despite receiving lipid lowering therapy consisting of statins with or without ezetimibe to receive placebo or 100, 150 or 300 mg REGN727 every 4 weeks or 150 mg REGN727 every 2 weeks. Data were published in The Lancet and presented at the European Atherosclerosis Society meeting in Milan. ...