POC for PCSK9
Regeneron, Sanofi have first proof of concept for PCSK9 mAb to lower cholesterol
Regeneron Pharmaceuticals Inc. and partner Sanofi have become the first companies to report Phase II proof-of-concept data that validate blocking PCSK9 as a strategy for lowering LDL-C in patients not controlled on standard statin therapy. The companies hope to cement their first-mover status by moving into Phase III by mid-2012.
Despite the success of statins, the need for new ways to lower LDL-C has never been greater, according to Regeneron EVP and CSO George Yancopoulos. "Statins lower cholesterol by 40-50% when taken by intensive dosing regimens, but there are still millions of people not reaching their cholesterol goal who are thus left at high cardiovascular risk," he said.