Sanofi, Regeneron report more data for PCSK9 inhibitor

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said subcutaneous alirocumab ( REGN727) met the primary endpoint in nine Phase III trials of the human mAb targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). The partners aren't yet reporting detailed data from the trials. In eight trials, the primary endpoint was a statistically significant reduction in LDL-C from baseline to week 24 vs. placebo or an active comparator. Four of the trials enrolled patients with hypercholesterolemia and a high cardiovascular risk not adequately controlled with lipid-lowering therapy; two of the trials enrolled patients with heterozygous familial hypercholesterolemia (heFH) not adequately controlled with lipid-lowering therapy; and one of the trials enrolled patients with primary hypercholesterolemia with a history of intolerance to at least two statins and a moderate to very high CV risk.

In the ninth trial -- the 2,341-patient ODYSSEY LONG TERM trial -- alirocumab met the primary endpoint of reductions in LDL-C at week 24. Additionally, a post hoc analysis showed a significantly lower rate of adjudicated major CV events in the alirocumab arm compared to the placebo arm (p<0.05). The trial enrolled hypercholesterolemia patients with high CV risk not adequately controlled with lipid-lowering therapy. ...