Date: 2012-11-05
Type of information:
phase: 3
Announcement: initiation of patient recruitment in the ODYSSEY OUTCOMES trial
Company: Sanofi (France) Regeneron Pharmaceutical (USA)
Product: SAR236553/REGN727
Action mechanism: SAR236553 / REGN727 is a subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in clinical development. By inhibiting PCSK9, a determinant of circulating LDL-cholesterol levels in the blood, REGN727 increases the number of free LDL receptors which can bind to circulating LDL and clear it from the bloodstream. REGN727 was created using Regeneron's pioneering VelocImmune® technology and is being developed by Regeneron in collaboration with Sanofi.
Disease: evaluation of the incidence of cardiovascular events in patients who have experienced an ACS and are not at their LDL-C goal
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: 49 countries
Trial
details: 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.
With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 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.
Latest
news: Sanofi and Regeneron Pharmaceuticals have announced that the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients.
The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents.
