Sanofi and Regeneron Pharmaceuticals have entered into a 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), which is known to contribute to circulating low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron.
ACC will use its clinical research expertise and utilize its extensive registries to identify patients who might be appropriate candidates for the Phase III ODYSSEY outcomes trial. ACC will also provide a comprehensive educational program for both physicians and patients aimed at expanding knowledge and understanding of the value of clinical research.
"This project represents another example of how medical registries can help transform medicine," said Ralph Brindis, past president of the ACC and senior medical officer of external affairs for the National Cardiovascular Data Registries (NCDR). "The ACC's registries and related provider networks support quality improvement programs for practitioners. For the first time, through our PINNACLE ambulatory office-based registry of the NCDR, we will be helping to solve the difficult problem of identifying physicians with patients who may be eligible for a clinical trial."
"Through this collaboration, we hope to provide better access to our Phase III ODYSSEY trial," said Jay Edelberg, M.D., Ph.D. vice president, PCSK9 Development and Launch Unit, Sanofi. This is the first time that ACC's PINNACLE Registry will be used for clinical trial recruitment, and we believe this novel approach will help trial sites meet and hopefully exceed their recruitment goals."