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12:00 AM
 | 
Nov 21, 2011
 |  BioCentury  |  Product Development

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.

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme that plays a role in cholesterol homeostasis by inducing degradation of the LDL receptors that would otherwise clear LDL-C from the bloodstream.

Yancopoulos said Regeneron set out to discover mAbs against PCSK9 in 2008 based on research from Helen Hobbs, a professor of internal medicine and molecular genetics at the University of Texas Southwestern Medical Center at Dallas.

Using data from a 3,500-patient observational study she was running at the time, Hobbs searched for mutations associated with low plasma levels of LDL-C. She identified an inactivating mutation in the PCSK9 gene that disrupts protein function and is associated with increased LDL receptor...

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