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March 26, 2012 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that data from two Phase 2 trials with
SAR236553/REGN727, an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), were presented at the American College of Cardiology's (ACC) 61st Annual Scientific Meeting in
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The data showed that treatment with
SAR236553/REGN727 over 8 to 12 weeks significantly reduced mean low-density lipoprotein-cholesterol (LDL-C, or "bad" cholesterol) by 40% to 72% in patients with elevated LDL-C on stable dose of statins.(1),(2)
Many patients are not able to lower their LDL-C sufficiently by diet and medication despite the availability of statins. As guidelines are evolving, there is a real need for additional lipid-lowering medications," said Dr.
James McKenney, President and CEO of National Clinical Research, Inc., Professor Emeritus of the
Virginia Commonwealth University School of Pharmacy,
USA, and Principal Investigator of the study. "
These trial results suggest that SAR236553/REGN727 may enable patients for whom statins are insufficient to further reduce LDL-C."
Presented today in a late-breaking clinical trials session at the ACC meeting, "Study DFI11565," the Phase 2 dose-finding clinical trial enrolled 183 patients with elevated LDL-C (greater than or equal to 100 mg/dL) despite being on a stable dose of atorvastatin. The objective of the study was to evaluate the effect of adding
SAR236553/REGN727 to existing statin therapy. Across the five different dose regimens tested, patients receiving
SAR236553/REGN727 for 12 weeks achieved and sustained a mean LDL-C reduction from baseline of 40% to 72%, compared to 5% in patients receiving placebo (p<0.0001). Patients in the study were followed for a total of 20 weeks for safety.
The most common adverse events (AEs) with
SAR236553/REGN727 were injection site reactions. Serious AEs occurred in one patient receiving placebo and three patients in the active treatment arms, including a patient on active treatment who experienced a skin rash diagnosed as leukocytoclastic vasculitis. Six patients, all on active treatment, prematurely discontinued therapy due to AEs. Muscle complaints were infrequent and similar across all treatment groups. There were no significant elevations in liver enzymes or other lab values in patients on active treatment.
"So far, SAR236553/REGN727 has demonstrated LDL-lowering efficacy and a generally acceptable safety profile," said
George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Research Laboratories.
"PCSK9 inhibition is being investigated for its potential to lower LDL-C in patients who cannot achieve their goals with standard therapies."
The PCSK9 mechanism is an example of how the study of genetics can identify new targets for developing new therapies.(3),(4) The role of PCSK9 in lipid metabolism was discovered a few years ago based on population studies.(5)