Alirocumab Meets Primary Endpoint in Six Hypercholesterolemia Trials

Sanofi and Regeneron announced positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced LDL-C in hypercholesterolemic patients. Alirocumab is an investigational fully human monoclonal antibody targeting the protein PCSK9 which is being evaluated for its ability to lower LDL-C.

The primary efficacy endpoint for all six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, was the percent change from baseline in LDL-C at 24 weeks. The primary endpoint was met with a greater reduction in LDL-C at 24 weeks, vs. either the active comparator or placebo. The trials assessed alirocumab in hypercholesterolemic patients who were at high cardiovascular (CV) risk, had an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), and/or a history of intolerance to two or more statins, including one at the lowest dose. All patients received alirocumab in addition to standard-of-care lipid-lowering therapy, with the exception of some patients in ODYSSEY ALTERNATIVE.

RELATED: Alirocumab Demonstrates Efficacy in Four Phase 3 Trials

Summary of primary efficacy endpoints:

  • LONG TERM (all patients with high CV risk; n=2,341): 61% reduction in LDL-C in alirocumab arm vs. 1% increase in placebo arm
  • LONG TERM (HeFH subgroup; n=416): 56% reduction in LDL-C in alirocumab arm vs. 7% increase in placebo arm
  • LONG TERM (Non-HeFH subgroup; n=1,894): 62% reduction in LDL-C in alirocumab arm vs. 0.5% reduction in placebo arm
  • COMBO I (High CV risk): 48% reduction in LDL-C in alirocumab arm vs. 2% reduction in placebo arm
  • OPTIONS I (High CV risk): 44–54% reduction in LDL-C in alirocumab arm vs. 20.5–23% reduction in ezetimibe arm, 5% reduction in double atorvastatin arm, and 21% reduction in switch to rosuvastatin arm
  • OPTIONS II (High CV risk): 31–51% reduction in LDL-C in alirocumab arm vs. 11–14% reduction in ezetimibe arm and 16% reduction in double rosuvastatin dose
  • ALTERNATIVE (High CV risk and history of intolerance to two or more statins): 45% reduction in LDL-C in alirocumab arm vs. 15% reduction in ezetimibe arm
  • HIGH FH (HeFH): 46% reduction in LDL-C in alirocumab arm vs. 7% reduction in placebo arm

For more information visit Sanofi.com or Regeneron.com.

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