Sanofi and leading science-based biopharmaceutical company, Regeneron Pharmaceuticals, Inc. have collaborated with the American College of Cardiology (ACC) which will focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating lowdensity lipoprotein cholesterol (LDL-C) levels.
Alirocumab is being co-developed by Sanofi and Regeneron.
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 III ODYSSEY OUTCOMES clinical trial. This Data Driven Trial Recruitment Programme 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.
"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 OUTCOMES Trial,” said Jay Edelberg, MD, 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.”
ODYSSEY is the global phase III trial programme 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 trials will evaluate alirocumab in combination with other lipid-lowering agents or as monotherapy across a broad patient population, including high cardiovascular risk patients with primary hypercholesterolemia, patients with primary hypercholesterolemia unable to tolerate statins, and patients with heterozygous familial hypercholesterolemia (HeFH) who are inadequately controlled by current lipid-modifying therapy.
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.
The ODYSSEY phase III trials are designed to create options to help meet the needs of individual patients. Patients in the majority of ODYSSEY trials will receive a 75mg Q2w (once every two weeks) dose of alirocumab, and will only be up-titrated to 150mg Q2w if they do not show sufficient low-density lipoprotein cholesterol (LDL-C) lowering (to their target level based on risk) after eight weeks. In addition, ODYSSEY CHOICE I is evaluating alirocumab dosed once every four weeks.
All of the ODYSSEY trials, with the exception of ODYSSEY CHOICE I and ODYSSEY CHOICE II and ODYSSEY OUTCOMES, are fully enrolled.
PCSK9 is known to be a determinant of circulating LDL levels, as it binds to LDL receptors resulting in their degradation so that fewer are available on liver cells to remove excess LDL-cholesterol 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-cholesterol. Blocking the PCSK9 pathway is therefore a potentially novel mechanism for lowering LDL-cholesterol.
Sanofi, an integrated global 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.
Regeneron is a leading science-based biopharmaceutical company which discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.