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Sanofi and Regeneron Launch Comprehensive Phase 3 Clinical Program With LDL Cholesterol-Lowering PCSK9 Antibody
Date:7/19/2012

receptors resulting in their degradation so that fewer are available on liver cells to remove LDL-C from the blood.  Moreover, traditional LDL-lowering therapies such as statins actually stimulate the production of PCSK9, which limits their own ability to lower LDL-C.  Inhibiting the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-C.

About SAR236553/REGN727 and the Phase 2 Program

SAR236553/REGN727, created using Regeneron's VelocImmune® technology, 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 clear circulating LDL-C from the bloodstream.

SAR236553/REGN727 has been studied in three Phase 2 clinical studies: two in patients with primary hypercholesterolemia and one in patients with heterozygous familial hypercholesterolemia (heFH).  In the primary hypercholesterolemia trials treatment with different dose regimens of SAR236553/REGN727 on top of statin therapy significantly reduced LDL-C from baseline by 40% to 72% over the 8 or 12-week treatment period.  A third Phase 2 study was in patients with heFH whose LDL-C levels remained elevated despite statin therapy with or without ezetimibe.  Across the four tested doses of SAR236553/REGN727 administered for up to 12 weeks, patients achieved a mean reduction in LDL-C from baseline of 28% to 68%.  In the Phase 2 program, injection site reactions were the most common adverse events with SAR236553/REGN727.  Rare cases of hypersensitivity reaction were also reported.  There were five serious adverse events (SAE) in the active treatment arms (1.8%, 5/275) and two SAEs in the placebo groups (2.6%, 2/77).

About the Phase 3 SAR236553/REGN727 Program

The Phase 3 ODYSSEY program will include over ten cli
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SOURCE Sanofi and Regeneron Pharmaceuticals, Inc.
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