Regeneron, Sanofi report Japanese alirocumab data

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said subcutaneous alirocumab ( REGN727) given every other week in combination with statin therapy met the primary endpoint vs. placebo in a Japanese Phase II trial to treat primary hypercholesterolemia. In the trial, 50, 75 or 150 mg alirocumab led to a greater mean percent reduction in LDL-C from baseline to week 12 vs. placebo (55%, 62% and 72%, respectively, vs. 3%, p<0.0001 for all). The trial enrolled 100 Japanese patients with LDL-C greater than 100 mg/dL who were on stable lipid-lowering therapy.

Last year, the partners reported that alirocumab met the primary endpoint in the Phase III ODYSSEY MONO trial to treat primary hypercholesterolemia. The data are the first for the 12-trial Phase III ODYSSEY program evaluating alirocumab as monotherapy and in combination with other lipid-lowering agents. Regeneron plans to submit regulatory applications for the human mAb targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) in early 2015 (see BioCentury Extra, Oct. 16, 2013). ...