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Sanofi and Regeneron’s alirocumab Phase III ODYSSEY trials meet primary endpoints

Sanofi and Regeneron Pharmaceuticals have reported positive results from two new Phase III ODYSSEY trials, which evaluated alirocumab that was administered every four weeks to patients with hypercholesterolemia.

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Both the trials, which met their primary efficacy endpoints, compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks with alirocumab versus placebo in these patients.

Alirocumab is an investigational monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).

The ODYSSEY CHOICE I trial evaluated the efficacy and safety of alirocumab in 803 patients with hypercholesterolemia at moderate to high cardiovascular (CV) risk.

The trial compared alirocumab 300mg every four weeks with placebo, with over 68% of patients also received statin therapy.

Around 233 hypercholesterolemia patients with high CV risk and/or a history of intolerance to two or more statins were evaluated in the ODYSSEY CHOICE II trial, which compared alirocumab 150mg every four weeks with placebo and no patients received statin therapy.

Regeneron vice president Program Direction, Cardiovascular and Metabolic Bill Sasiela said: "In the new monthly dosing trials, ODYSSEY CHOICE I and CHOICE II, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous phase III trials evaluating alirocumab every other week dosing.

"These results continue to validate our clinical development approach, which is designed to investigate various alirocumab doses and intervals to address patients’ lipid-lowering needs."

The company said that in both trials, alirocumab-treated patients who did not achieve their pre-specified LDL-C goals, or who did not achieve at least a 30% reduction in their LDL-C levels from baseline, were switched to receive alirocumab 150mg every two weeks at 12 weeks.

Sanofi head of the PCSK9 Development & Launch Unit Jay Edelberg said: "Despite current lipid-lowering therapies, many patients at high CV risk struggle to reach optimal LDL-C levels.

"The ODYSSEY clinical trial program has provided key insights and allowed us to investigate alirocumab administered every four weeks in different patient populations, including those who cannot get control of their high LDL-C because of difficulty tolerating statin therapy."


Image: Both the trials compared reduction from baseline in LDL-C at 24 weeks with alirocumab versus placebo in patients with hypercholesterolemia. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.