Positive Phase 3 Results for New Cholesterol Tx Presented

Regeneron and Sanofi announced that, in a new pooled analysis of heterozygous familial hypercholesterolemia (HeFH) patients included in the ODYSSEY clinical trial program, Praluent (alirocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C).

The analysis presented at the European Society of Cardiology Congress 2015 evaluated the efficacy and safety of Praluent compared to placebo in 1,257 patients with HeFH, the largest group of HeFH patients ever studied in a Phase 3 program. Data from four Phase 3 ODYSSEY trials, LONG TERM (HeFH patients only), HIGH FH, FH I, and FH II, were included. In these trials, patients either received Praluent or placebo, in addition to standard-of-care, which included maximally-tolerated statins with or without other lipid-lowering therapies such as ezetimibe.

Across all primary and secondary endpoints assessed, there were statistical differences in favor of Praluent compared to placebo. Patients treated with Praluent achieved average LDL-C levels of <85mg/dL at week 12, and maintained reductions through 78 weeks of therapy. At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56% greater reduction in LDL-C compared to placebo (P<0.0001) in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy.

Praluent, a human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease (ASCVD), who require additional lowering of LDL-C.

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