Sanofi and Regeneron launch phase 3 clinical program

Hannah Blake

pharmaphorum

Sanofi and Regeneron Pharmaceuticals, Inc. have announced that several clinical trials have initiated patient enrolment, in a Phase 3 clinical program of SAR236553/REGN727 called ODYSSEY.

SAR236553/REGN727 is a potential, first-in-class, subcutaneously administered, fully-human antibody that lowers low-density lipoprotein (LDL) cholesterol, by targeting proprotein convertase subtilisin / kexin type 8 (PCSK9), which is an enzyme that binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) levels.

“This comprehensive Phase 3 program will test the safety and efficacy of SAR236553/REGN727 administered as one single injection every two weeks in multiple treatment strategies and patient types, such as those who are at elevated cardiovascular risk, are unable to tolerate statin therapy, or have familial hypercholesterolemia.”

Jay Edelberg M.D., Ph.D., Head of the PCSK9 Development and Launch Unit, Sanofi.

The ODYSSEY program will enrol over 22,000 patients for over ten clinical trials that will evaluate the effect of SAR236553/REGN727 on the lowering of LDL cholesterol as well as an 18,000 patient cardiovascular outcomes study. The studies will be conducted in clinical centers around the world, including the United States, Asia and Europe.