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Alirocumab meets primary endpoints in ODYSSEY CHOICE trials
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Sanofi and Regeneron Pharmaceuticals Inc. announced that the phase 3 ODYSSEY CHOICE I and CHOICE II trials had each met their primary efficacy endpoints for monthly treatment with alirocumab in patients with hypercholesterolemia.
According to a press release, both trials compared alirocumab, a PCSK9 inhibitor, to placebo at 24 weeks for the reduction of LDL cholesterol. ODYSSEY CHOICE I included 803 patients with hypercholesterolemia and moderate-to-high CV risk. Patients received 300 mg alirocumab or placebo every 4 weeks, while 68% of participants also received statins. ODYSSEY CHOICE II included 233 patients with hypercholesterolemia who had high CV risk and/or intolerance to at least two statins. In this trial, patients received 150 mg alirocumab or placebo every 4 weeks, and no participants received statin therapy.
“In the new monthly dosing trials … the mean percent reduction in LDL [cholesterol] from baseline was consistent with that seen in previous phase 3 trials evaluating alirocumab every other week dosing,” Bill Sasiela, PhD, vice president of program direction, cardiovascular and metabolic, for Regeneron, said in the release.
Adverse events that occurred in 5% or more of treated patients included reactions at the injection site, headache, upper respiratory tract infection, nausea, extremity pain and fatigue, according to the release. Reactions at the injection site were more common among treated patients than placebo recipients.
Further data will be presented at future medical congresses, according to the release.