Date: 2013-12-19
Type of information: Clinical research agreement
Compound: alirocumab (SAR236553/REGN727)
Company: Sanofi (France) Regeneron Pharmaceutical (USA - NY) American College of Cardiology (USA)
Therapeutic area: Cardiovascular diseases - Genetic diseases - Rare diseases
Type agreement: R&D
clinical research
Action mechanism:
Disease: patients with heterozygous familial hypercholesterolemia (heFH), patients with primary hypercholesterolemia with elevated LDL-C
Details: * On December 19, 2013, Sanofi and Regeneron Pharmaceuticals have announced an innovative collaboration with the American College of Cardiology (ACC) focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). Under the terms of the agreement, the ACC will apply its expertise in clinical research and utilize its extensive registries to identify patients who might be appropriate candidates for the Phase 3 ODYSSEY OUTCOMES clinical trial. This Data Driven Trial Recruitment Program is a new approach to identification and recruitment of patients for the clinical trial. Additional activities under the collaboration include a comprehensive educational program for both physicians and patients with the goal to broaden knowledge and understanding of the value of clinical trial research.
ODYSSEY is the global Phase 3 trial program for investigational compound alirocumab. ODYSSEY currently comprises at least 12 clinical trials enrolling more than 23,000 patients with hypercholesterolemia in 2,000 study centers across North and South America, Europe, Australia, South Africa and Asia. The primary study endpoint in the ODYSSEY trials (except ODYSSEY OUTCOMES) is mean percentage LDL-C reduction at 24 weeks. Several other lipid markers will be evaluated, and trials will continue up to 24 months. In ODYSSEY OUTCOMES, 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. All of the ODYSSEY trials, with the exception of ODYSSEY CHOICE I and ODYSSEY CHOICE II and ODYSSEY OUTCOMES, are fully enrolled.
Financial terms:
Latest news:
