Sanofi and Regeneron announced positive results from the Phase 3 ODYSSEY ESCAPE trial evaluating Praluent (alirocumab) Injection in patients with heterozygous familial hypercholesterolemia (HeFH), whose cholesterol levels required chronic, weekly or bi-weekly LDL apheresis therapy.
ODYSSEY ESCAPE is a double-blind, placebo-controlled Phase 3 trial evaluating Praluent in 62 patients with HeFH undergoing regular baseline apheresis therapy at fixed intervals of every week or every 2 weeks prior to randomization. Patients received either Praluent 150mg SC every 2 weeks or placebo, in addition to existing treatment regimen. The primary endpoint was reduction in the frequency of apheresis therapy compared to placebo.
Results from the study showed that patients who added Praluent to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75% vs. placebo (P<0.0001), meeting the trial’s primary endpoint. In addition, 63% of patients treated with Praluent no longer required apheresis vs. 0% in the placebo-treated group. Detailed findings for ODYSSEY ESCAPE will be presented at future medical congresses.
Praluent, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol.