Sanofi and Regeneron recruiting patients for cardiovascular outcomes trial with antibody to PCSK9 for hypercholesterolemia

French drug major Sanofi (Euronext: SAN) and US partner Regeneron Pharmaceuticals (Nasdaq: REGN) say that the ODYSSEY OUTCOMES trial, a Phase III cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. The drug candidate is part of a new class of medicines to treat patients who cannot lower their low density lipoprotein (LDL) cholesterol through widely used statin, and has been forecast as having blockbuster status.

SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering LDL-C by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase III program.

“Despite widespread use of statin therapy, many patients at risk do not reach recommended targets for LDL. Even among those who do reach targets, further LDL lowering may further reduce the risks of coronary heart disease (CHD) death, myocardial infarction (MI) and stroke,” said Gabriel Steg, Professor of Cardiology at the Hopital Bichat-Claude Bernard in Paris, France, and co-chair of the ODYSSEY OUTCOMES Steering Committee, adding: “The ODYSSEY cardiovascular (CV) outcomes trial will test the efficacy and safety of SAR236553/REGN727 added to maximal doses of statins in reducing cardiovascular morbidity and mortality in patients with recent ACS, a population at high risk of CV events despite best contemporary therapy."