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Sanofi and Regeneron Announce Publication of Positive Phase 2 Results for Lipid-Lowering PCSK9 Antibody in The Lancet
Date:5/26/2012

up>4] Moreover, traditional LDL-lowering therapies such as statins actually stimulate the production of PCSK9, which limits their own ability to lower LDL-C.[5] Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-C.

About SAR236553/REGN727 and the Phase 2 Heterozygous Familial Hypercholesterolemiatrial

SAR236553/REGN727 is a fully human monoclonal antibody directed against PCSK9, administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood, SAR236553/REGN727 increases the number of free LDL receptors which can bind to circulating LDL-C and clear it from the bloodstream. SAR236553/REGN727 was created using Regeneron's VelocImmune® technology.

Study 1003 was a randomized, double-blind, placebo-controlled, dose-finding study in patients with heFH. The primary objective of the trial was to assess the efficacy of various subcutaneous doses and dosing regimens of SAR236553/REGN727 on LDL-C in patients with heFH. Seventy-seven patients were randomized to either placebo or one of four active dose regimens of 150 mg at four-week intervals (Q4W), 200 mg Q4W, 300 mg Q4W, or 150 mg at two-week intervals (Q2W). At baseline, all patients had LDL-C greater than or equal to 100 mg/dL (2.59 mmol/L) and were on stable daily statin therapy (the type and dosage of statin was at the discretion of the investigator) with or without ezetimibe, for at least six weeks prior to screening. The majority of patients, 77%, were taking a high intensity dose of a statin, and 71% were also taking ezetimibe 10 mg at the time of the screening visit and throughout the trial. Despite this aggressive therapy, the mean baseline LDL-C for all study participants was approximately 155 mg/dL (4 mmol/L). The primary endpoint of the study was the change in LDL-C from baseline over the 12-week study period. Patients were followed for
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