LDL Cholestrol-Lowering Antibody Enters Phase 3 Trials
Sanofi and Regeneron Pharmaceuticals, Inc. announced on July 20 that several trials within ODYSSEY, the phase III clinical program for the investigational antibody SAR236553/REGN727, have begun patient enrollment.
SAR236553/REGN727 is a potential first-in-class, subcutaneously administered, fully human antibody that lowers low-density lipoprotein (LDL) cholesterol levels by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that binds LDL receptors, leading to their accelerated degradation and increased LDL-cholesterol (LDL-C) levels.
The phase III ODYSSEY program will include more than 10 clinical trials designed to test the efficacy and long-term safety of SAR236553/REGN727, both as monotherapy and in combination with other lipid-lowering agents.
ODYSSEY will enroll several patient populations, including patients with heterozygous familial hypercholesterolemia (heFH) who are inadequately controlled by current lipid-modifying therapy, and patients with primary hypercholesterolemia who are at high cardiovascular risk. The primary efficacy parameter will be LDL-C; however, multiple lipid parameters will also be evaluated.
The global phase III program will be conducted at more than 2,000 centers worldwide, including sites in the U.S. and Canada.
Read the full news release here.