Sanofi and Regeneron's alirocumab meets endpoints in cholesterol study

French pharma major Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals (Nasdaq: REGN) today announced that two new ODYSSEY trials, which are the first Phase III trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints.

The trials compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol) at 24 weeks with alirocumab versus placebo in patients with hypercholesterolemia. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

"In the new monthly dosing trials, ODYSSEY CHOICE I and CHOICE II, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous Phase III trials evaluating alirocumab every other week dosing,"said Bill Sasiela, vice president, program direction, cardiovascular and metabolic, at Regeneron, adding: "These results continue to validate our clinical development approach, which is designed to investigate various alirocumab doses and intervals to address patients' lipid-lowering needs."