Sanofi, Regeneron initiate Phase III cardiovascular outcomes trial

5th November 2012 (Last Updated August 9th, 2019 09:29)

Sanofi and Regeneron Pharmaceuticals have announced the initiation of patient recruitment in a Phase III cardiovascular outcomes trial (CVOT) evaluating SAR236553/REGN727.

Sanofi and Regeneron Pharmaceuticals have announced the initiation of patient recruitment in a Phase III cardiovascular outcomes trial (CVOT) evaluating SAR236553/REGN727.

The Odyssey Outcomes trial will enrol 18,000 patients to assess the impact of the fully human antibody that targets proprotein convertase subtilisin/kexin type 9, in lowering low-density lipoprotein cholesterol (LDL-C).

Odyssey Outcomes Steering Committee co-chair and Hopital Bichat-Claude Bernard in Paris professor of cardiology, Dr 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," Steg said.

"The Odyssey Outcomes trial will enrol 18,000 patients to assess the impact of the fully human antibody that targets proprotein convertase subtilisin/kexin type 9, in lowering low-density lipoprotein cholesterol (LDL-C)."

"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."

Patients with an acute coronary syndrome (ACS) and who are not at their LDL-C goal will participate in the double-blind study.

The multi-national study will randomise patients with either a 75mg/ml SAR236553/REGN727 injection or placebo for every two weeks, in addition the patients' optimised lipid-lowering therapy.

An increased dose of 150mg/ml will be given to subjects not reaching a predetermined LDL-C goal with the 75mg dose.

The effect of the investigational candidate on occurrence of cardiovascular events including coronary heart disease death, non-fatal MI, fatal and non-fatal ischemic stroke, and unstable angina requiring hospitalisation is the primary objective of the study.