18,000 patient Phase 3 outcomes study will evaluate the impact of antibody to PCSK9 on cardiovascular events
PARIS, France and TARRYTOWN, NY, USA I November 5, 2012 I Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 program.
"Despite widespread use of statin therapy, many patients at risk do not reach recommended targets for LDL. Even among those who do reach targets, further LDL lowering may further reduce the risks of coronary heart disease (CHD) death, myocardial infarction (MI) and stroke," said Ph. Gabriel Steg M.D., Professor of Cardiology at the Hopital Bichat-Claude Bernard in Paris, France, and co-Chair of the ODYSSEY OUTCOMES Steering Committee. "The ODYSSEY cardiovascular (CV) outcomes trial will test the efficacy and safety of SAR236553/REGN727 added to maximal doses of statins in reducing cardiovascular morbidity and mortality in patients with recent ACS, a population at high risk of CV events despite best contemporary therapy."
ODYSSEY OUTCOMES is a double-blind, randomized, placebo-controlled, multi-national study. The primary objective of the study is to evaluate the effect of SAR236553/REGN727 on the incidence of cardiovascular events in patients who have experienced an ACS and are not at their LDL-C goal. Patients will receive either a 1-milliliter (mL) injection of 75 milligrams (mg) of SAR236553/REGN727 or placebo every two weeks, in addition to their background of optimized lipid-lowering therapy. If patients do not reach a predetermined LDL-C goal with the 75 mg dose they will be up-titrated to a dose of 150 mg, also delivered as a 1 mL injection. The primary endpoint is a composite of coronary heart disease (CHD) death, non-fatal MI, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization. ODYSSEY OUTCOMES is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).
About the Ongoing Phase 3 ODYSSEY Program
The broad Phase 3 ODYSSEY program is underway and will be conducted across more than 2,000 study centers across the United States, Canada, Western and Eastern Europe, South America, Australia and Asia. In addition to ODYSSEY OUTCOMES, the Phase 3 ODYSSEY program includes the following studies:
ODYSSEY FH I, FH II and HIGH FH, in patients with heFH who are not adequately controlled with their lipid-modifying therapy.
ODYSSEY COMBO I and COMBO II, in patients with primary hypercholesterolemia at high cardiovascular risk who are not adequately controlled with their lipid-modifying therapy.
ODYSSEY MONO, in patients with primary hypercholesterolemia.
ODYSSEY ALTERNATIVE, in patients with primary hypercholesterolemia (heFH and non-familial hypercholesterolemia) who are unable to tolerate statins.
ODYSSEY OPTIONS I and OPTIONS II, in patients with primary hypercholesterolemia at high cardiovascular risk or with heFH who are not adequately controlled on statins, in comparison to several second-line lipid-lowering strategies.
ODYSSEY LONG TERM, in patients with hypercholesterolemia at high cardiovascular risk or patients with heFH inadequately controlled with their current lipid-modifying therapy.
Based on the cumulative efficacy and safety data from the SAR236553/REGN727 Phase 1 and Phase 2 clinical studies, 75 mg and 150 mg Q2W doses were chosen to be tested in the Phase 3 program. The selection of these doses was also supported by information from current lipid treatment guidelines and data from large, completed CV event trials that have demonstrated a correlation between the degree of LDL-C lowering and the resultant lowered risk for CV events.
Further information about the initiated Phase 3 studies can be found at www.clinicaltrials.gov.
About PCSK9
PCSK9 is known to be a determinant of circulating LDL-C levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess 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. Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-C.
About SAR236553/REGN727
SAR236553/REGN727, created using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody targeting PCSK9, administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood, SAR236553/REGN727 has been shown in pre-clinical studies to increase the number of LDL receptors which can clear circulating LDL-C from the bloodstream.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 76
18,000 patient Phase 3 outcomes study will evaluate the impact of antibody to PCSK9 on cardiovascular events
PARIS, France and TARRYTOWN, NY, USA I November 5, 2012 I Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).
The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 program.
"Despite widespread use of statin therapy, many patients at risk do not reach recommended targets for LDL. Even among those who do reach targets, further LDL lowering may further reduce the risks of coronary heart disease (CHD) death, myocardial infarction (MI) and stroke," said Ph. Gabriel Steg M.D., Professor of Cardiology at the Hopital Bichat-Claude Bernard in Paris, France, and co-Chair of the ODYSSEY OUTCOMES Steering Committee. "The ODYSSEY cardiovascular (CV) outcomes trial will test the efficacy and safety of SAR236553/REGN727 added to maximal doses of statins in reducing cardiovascular morbidity and mortality in patients with recent ACS, a population at high risk of CV events despite best contemporary therapy."
ODYSSEY OUTCOMES is a double-blind, randomized, placebo-controlled, multi-national study. The primary objective of the study is to evaluate the effect of SAR236553/REGN727 on the incidence of cardiovascular events in patients who have experienced an ACS and are not at their LDL-C goal. Patients will receive either a 1-milliliter (mL) injection of 75 milligrams (mg) of SAR236553/REGN727 or placebo every two weeks, in addition to their background of optimized lipid-lowering therapy. If patients do not reach a predetermined LDL-C goal with the 75 mg dose they will be up-titrated to a dose of 150 mg, also delivered as a 1 mL injection. The primary endpoint is a composite of coronary heart disease (CHD) death, non-fatal MI, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization. ODYSSEY OUTCOMES is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).
About the Ongoing Phase 3 ODYSSEY Program
The broad Phase 3 ODYSSEY program is underway and will be conducted across more than 2,000 study centers across the United States, Canada, Western and Eastern Europe, South America, Australia and Asia. In addition to ODYSSEY OUTCOMES, the Phase 3 ODYSSEY program includes the following studies:
ODYSSEY FH I, FH II and HIGH FH, in patients with heFH who are not adequately controlled with their lipid-modifying therapy.
ODYSSEY COMBO I and COMBO II, in patients with primary hypercholesterolemia at high cardiovascular risk who are not adequately controlled with their lipid-modifying therapy.
ODYSSEY MONO, in patients with primary hypercholesterolemia.
ODYSSEY ALTERNATIVE, in patients with primary hypercholesterolemia (heFH and non-familial hypercholesterolemia) who are unable to tolerate statins.
ODYSSEY OPTIONS I and OPTIONS II, in patients with primary hypercholesterolemia at high cardiovascular risk or with heFH who are not adequately controlled on statins, in comparison to several second-line lipid-lowering strategies.
ODYSSEY LONG TERM, in patients with hypercholesterolemia at high cardiovascular risk or patients with heFH inadequately controlled with their current lipid-modifying therapy.
Based on the cumulative efficacy and safety data from the SAR236553/REGN727 Phase 1 and Phase 2 clinical studies, 75 mg and 150 mg Q2W doses were chosen to be tested in the Phase 3 program. The selection of these doses was also supported by information from current lipid treatment guidelines and data from large, completed CV event trials that have demonstrated a correlation between the degree of LDL-C lowering and the resultant lowered risk for CV events.
Further information about the initiated Phase 3 studies can be found at www.clinicaltrials.gov.
About PCSK9
PCSK9 is known to be a determinant of circulating LDL-C levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess 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. Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-C.
About SAR236553/REGN727
SAR236553/REGN727, created using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody targeting PCSK9, administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDL-C levels in the blood, SAR236553/REGN727 has been shown in pre-clinical studies to increase the number of LDL receptors which can clear circulating LDL-C from the bloodstream.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets three products in the United States, EYLEA® (aflibercept) Injection, ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, and ARCALYST® (rilonacept) Injection for Subcutaneous Use; ZALTRAP is co-commercialized with Sanofi. Phase 3 studies are in progress with EYLEA in two additional indications and with product candidates sarilumab and REGN727. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 76
