Sanofi, Regeneron report detailed alirocumab data

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) presented detailed data at the European Society of Cardiology meeting in Barcelona from four Phase III trials of subcutaneous alirocumab ( REGN727) to treat hypercholesterolemia. In July, the partners said the human mAb targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) met the primary endpoint in the trials of reducing LDL-C from baseline to week 24, but did not disclose details (see BioCentury Extra, July 30).

In the ODYSSEY LONG TERM trial, alirocumab reduced LDL-C from baseline to week 24 by 61% vs. a 1% increase for placebo and by 57% from baseline to week 52 vs. a 4% increase for placebo (p<0.0001 for both). Additionally, the partners said alirocumab led to a 1.4% rate of adjudicated major CV events vs. 3% for placebo in a post hoc analysis (p<0.01). ODYSSEY LONG TERM trial enrolled patients with hypercholesterolemia at a high or very high CV risk. ...