First Phase III data for PCSK9 inhibitor
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gained $17.22 to $307.65 on Wednesday after it and partner Sanofi (Euronext:SAN; NYSE:SNY) said subcutaneous alirocumab ( REGN727) met the primary endpoint in the Phase III ODYSSEY MONO trial to treat primary hypercholesterolemia. Alirocumab every two weeks reduced mean LDL-C from baseline to week 24 vs. Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK) (47.2% vs. 15.6%, p<0.0001). The double-blind, international trial enrolled 103 patients with primary hypercholesterolemia and moderate cardiovascular risk to receive alirocumab or Zetia monotherapy.
The ODYSSEY MONO data are the first data from the 12-trial Phase III ODYSSEY program evaluating alirocumab as monotherapy and in combination with other lipid-lowering agents in over 23,000 patients. Data from additional ODYSSEY trials are expected next year. Sanofi and Regeneron are co-developing the human mAb targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) under a 2007 deal. ...