Sanofi and Regeneron announced that the Phase 3 ODYSSEY MONO trial with alirocumab for the reduction in low-density lipoprotein-cholesterol (LDL-C) met its primary efficacy endpoint. Alirocumab is an investigational, fully-human monoclonal antibody that targets and blocks PCSK9.
ODYSSEY MONO was a randomized, double-blind, active-controlled, parallel-group study designed to evaluate the efficacy and safety of alirocumab over 24 weeks in patients (N=103) with primary hypercholesterolemia and moderate cardiovascular risk. Patients in the trial were randomized to receive monotherapy with either ezetimibe 10mg, an alternative to statin therapy, or alirocumab. Alirocumab was self-administered subcutaneously initially at 75mg every two weeks, and was titrated up at Week 12 to 150mg if the LDL-C measurement at Week 8 was >70mg/dL. The majority of alirocumab patients in the trial remained on the initial low dose of alirocumab because they achieved LDL-C <70mg/dL at Week 8.
The mean low-density lipoprotein-cholesterol (LDL-C) reduction from baseline to Week 24, the primary efficacy endpoint of the study, was significantly greater in patients randomized to alirocumab, as compared to patients randomized to ezetimibe (47.2% vs. 15.6%, P<0.0001). In the trial, which employed a dose increase for patients who did not achieve an LDL-C level of 70 mg/dL, the majority of patients remained on the initial low dose of alirocumab 75mg.