Alirocumab Meets Primary Endpoint in Hypercholesterolemia Trials

Sanofi and Regeneron announced results from nine new Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia. Alirocumab is an investigational monoclonal antibody targeting PCSK9.

The nine trials included ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II and ALTERNATIVE. The 2,341-patient ongoing ODYSSEY LONG TERM trial evaluated the long-term safety and efficacy of alirocumab compared to placebo. Both treatment groups received statins and some patients also received additional lipid-lowering therapies. All patients received alirocumab in addition to standard-of-care lipid-lowering therapy, with the exception of some patients in ODYSSEY ALTERNATIVE. A pre-specified interim safety analysis was performed when all patients reached one year and approximately 25% of patients reached 18 months of treatment.

RELATED: Alirocumab Successfully Reduces LDL Cholesterol in Clinical Trial

The primary endpoint in all nine ODYSSEY trials of a greater percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at 24 weeks compared to placebo or active comparator was met. The mean percent reduction in LDL-C from baseline at 24 weeks in alirocumab-treated patients was consistent with results seen in previous alirocumab trials. A lower rate of major cardiovascular events (cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization) was observed in the alirocumab arm vs. placebo in a post-hoc analysis (p-value <0.05). The potential of alirocumab to demonstrate cardiovascular benefit is being evaluated in an ongoing 18,000-patient ODYSSEY OUTCOMES trial.

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