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Sanofi And Regeneron Report Phase 2 Data For Potential First-in-Class Lipid-Lowering PCSK9 Antibody

About SAR236553/REGN727 and the Phase 2 primary hypercholesterolemia trials

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

Study 11565 was a randomized, double-blind, multi-dose, placebo-controlled, 183-patient trial in patients with primary hypercholesterolemia and on stable doses of atorvastatin. In this trial, patients on a stable dose of atorvastatin 10, 20 or 40 mg for at least 6 weeks with LDL-cholesterol levels greater than or equal to 100 mg/dL, or who had LDL-cholesterol levels greater than or equal to 100 mg/dL after a run-in period on atorvastatin 10, 20 or 40 mg, were randomized to one of five different dose regimens of SAR236553/REGN727 (i.e. either 50, 100, or 150 mg Q2W, or 200 or 300 mg Q4W alternating with placebo at 2 weeks) plus continued atorvastatin or placebo. The primary endpoint of the study was the change in LDL-cholesterol from baseline over the 12-week study period. Patients were followed for a total of 20 weeks for safety.

Study 11566 was a randomized, double-blind, multi-dose, placebo-controlled, 92-patient trial in patients with primary hypercholesterolemia. In this trial, patients on a stable dose of atorvastatin 10 mg for at least 6 weeks with LDL-cholesterol levels greater than or equal to 100 mg/dL, or who had LDL-cholesterol levels greater than or equal to 100 mg/dL after a run-in period on atorvastatin 10 mg, were randomized to either (a) titration from atorvastatin 10 mg to atorvastatin 80 mg plus SAR236553/REGN727 150 mg Q2W, (b) titration from atorvastatin 10 mg to atorvastatin 80 mg plus placebo, or (c) continued atorvastatin 10 mg plus SAR236553/REGN727 150 mg Q2W. The primary endpoint of the study was the change in LDL-cholesterol from baseline over the 8-week study period. Patients were followed for a total of 16 weeks for safety.

About primary hypercholesterolemia

Hypercholesterolemia, particularly an increase in LDL-C levels, is a major risk factor for the development of cardiovascular disease. LDL-C is identified as the primary target of cholesterol-lowering therapies such as statins, which have significantly helped in managing the risk for cardiovascular disease.(7) However, despite the availability of statins, many patients with hypercholesterolemia are not reaching their recommended LDL-C goal and need new additional therapy.

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