Sanofi and leading science-based biopharmaceutical company, Regeneron Pharmaceuticals, Inc. announced that data from alirocumab clinical studies will be presented at the American College of Cardiology's 63rd Annual Scientific Session in Washington, D.C. March 29-31. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) currently in phase 3 studies.
"ACC marks the beginning of the presentation of our phase 3 ODYSSEY data in 2014, with the first full data results from the phase 3 ODYSSEY MONO study," said Jay Edelberg, Head of the PCSK9 Development and Launch Unit, Sanofi Group. "We are presenting new data with our 150mg four-week dosing regimen in individuals not receiving statins and long term data in heterozygous familial hypercholesterolemia patients."
"Despite the availability of lipid-lowering therapies, millions of people worldwide are unable to satisfactorily control their levels of low-density lipoprotein-cholesterol," said George D Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "We have designed a robust phase 3 ODYSSEY programme that consists of 14 studies in more than 23,500 patients and we look forward to reporting phase 3 data from the majority of the ODYSSEY clinical studies later this year."
Sanofi and Regeneron are developing alirocumab as a potential new treatment for patients with moderate and high cardiovascular risk who face challenges in achieving control of their low-density lipoprotein-cholesterol (LDLc) levels. Sanofi and Regeneron plan to submit applications for global regulatory approval of alirocumab based on the phase 3 ODYSSEY programme.
Alirocumab is an investigational, fully-human monoclonal antibody that targets and blocks PCSK9. It is administered via subcutaneous injection. By inhibiting PCSK9, a determinant of circulating LDLc levels in the blood, alirocumab has been shown in pre-clinical studies to increase the number of LDL receptors on hepatocytes, thereby lowering LDLc.
ODYSSEY is the global phase 3 trial programme for investigational compound alirocumab. ODYSSEY currently comprises 14 clinical trials enrolling more than 23,500 patients with hypercholesterolemia in 2,000 study centers across North and South America, Europe, Australia, South Africa, and Asia. Alirocumab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.