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Sanofi, Regeneron commence patient recruitment in Phase 3 CVOT

Sanofi and Regeneron Pharmaceuticals have commenced patient recruitment in a Phase 3 cardiovascular outcomes trial (CVOT) to test SAR236553/REGN727, designed to lessen the low-density lipoprotein cholesterol (LDL-C) levels.

The 18,000 patient ODYSSEY OUTCOMES trial will assess the effect of the injected drug on proprotein convertase subtilisin/kexin type 9.

Patients with acute coronary syndrome (ACS) will participate in the double-blind, placebo-controlled, multi-national study.

The ODYSSEY OUTCOMES Steering Committee co-Chair and the Hopital Bichat-Claude Bernard in Paris, professor of cardiology, Ph. Gabriel Steg said many patients do not reach recommended targets for LDL in spite of the widespread use of statin therapy.

"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," Ph. Steg added.

"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."

Study will randomize patients with either SAR236553/REGN727 injection of 75mg/mL or placebo for every two weeks besides background of optimized lipid-lowering therapy.

A dose of 150mg/mL injection will be administered to patients who fail to reach a predetermined LDL-C goal with 75mg.

The effect of investigational human antibody on the rate of cardiovascular events such as composite of coronary heart disease death, non-fatal MI, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalization in ACS patients is the primary objective of the study.