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SAR 236553 success in Phase II study for heFH

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Last updated:29th May 2012
Published:29th May 2012
Source: Pharmawand
Sanofi and Regeneron have announced results from study 1003 of SAR 236553/REGN 727, a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) intended to treat Heterozygous Familial Hypercholesterolemia (heFH). The trial randomized 77 patients with heFH whose LDL-cholesterol (LDL-C) levels remained uncontrolled on statin therapy with or without ezetimibe. Across the four different dosing regimens tested, patients receiving SAR236553 / REGN727 for 12 weeks achieved a mean LDL-C reduction from baseline of 28.9% to 67.9%, compared to 10.7% in patients receiving placebo (p<0.05 ).in addition, in the most intense dose regimen tested where the greatest ldl-c reduction was observed (150 milligrams [mg] every two weeks), 93.8% of patients achieved ldl-c levels lower than 100 mg dl (2.59 mmol l), compared to 13.3% of patients on placebo, and 81.3% reached ldl-c levels lower than 70 mg dl (1.81 mmol l), compared to none on placebo.the results from this study were published online in the lancet and also presented at a late-breaking oral session at the 80th european atherosclerosis society congress (eas) in milan, italy. positive, top-line results from this study were announced in november 2011.see stein ea, et al. a randomized, double-blind, placebo-controlled trial of the safety and efficacy of a monoclonal antibody to pcsk9, regn727 sar236553, in heterozygous familial hypercholesterolemia patients on a stable statin dose with or without ezetimibe therapy. (nct:01266876). presented at the 80th eas congress, milan, italy; may 26, 2012. abstract #1398.the companies intend to initiate a global phase iii program with sar236553 regn727 in june. this will be the first phase iii program of an investigational drug targeting pcsk9.>

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