PARIS and TARRYTOWN, N.Y., 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 Chicago.
To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/55299-sanofi-regeneron-pharmaceuticals-lipid-lowering-medications-pcsk9-antibody
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)
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV