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

nical trials designed to test the efficacy and long-term safety of SAR236553/REGN727 both as monotherapy, and in combination with other lipid-lowering agents.  ODYSSEY will enroll several patient populations including patients with heFH who are inadequately controlled by current lipid-modifying therapy, and high cardiovascular risk patients with primary hypercholesterolemia.  The primary efficacy parameter will be LDL-C; however, multiple lipid parameters will be evaluated.  The global Phase 3 program will be conducted across more than 2,000 study centers across the United States, Canada, Western and Eastern Europe, South America, Australia and Asia.  The Phase 3 ODYSSEY program will include the following studies:

  • ODYSSEY FH I, FH II and HIGH FH: The primary objective of these three studies is to demonstrate the efficacy and safety of SAR236553/REGN727 as an add-on therapy in patients with heFH who are not adequately controlled with their lipid-modifying therapy.
  • ODYSSEY COMBO I and COMBO II: The primary objective of these two studies is to demonstrate the safety and efficacy of SAR236553/REGN727 as an add-on therapy in patients with primary hypercholesterolemia at high cardiovascular risk who are not adequately controlled with their lipid-modifying therapy.
  • ODYSSEY MONO: The primary objective of this study is to demonstrate the safety and efficacy of SAR236553/REGN727 as monotherapy in comparison with ezetimibe in patients with primary hypercholesterolemia.
  • ODYSSEY ALTERNATIVE: The primary objective of this study is to demonstrate the safety and efficacy of SAR236553/REGN727 in comparison with ezetimibe in patients with primary hypercholesterolemia (heFH and non-familial hypercholesterolemia) who are unable to tolerate statins.
  • ODYSSEY OPTIONS I and OPTIONS II: The primary objective of these studies is to evaluate the safety and efficacy of SAR236553/REGN727 as an add
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SOURCE Sanofi and Regeneron Pharmaceuticals, Inc.
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