New antibody treatment lowers bad cholesterol


New antibody treatment lowers bad cholesterol

Low-density lipoprotein-cholesterol (LDL-C) is the "bad" cholesterol, and despite many drugs including statins available to doctors, patients often have trouble reducing their blood level of LCL-C.

Sanofi and Regeneron presented data at The American College of Cardiology Meeting on 26th March 2012, showing an impressive reduction using their new antibody treatment known as SAR236553/REGN727. The human antibody is administered subcutaneously and targets PCSK9 (proprotein convertase subtilisin/kexin type 9).

Patients were treated over a period of 8 to 12 weeks and showed between 40 to 70+% reduction in LDL-C where their levels had previously remained stubbornly high using statins.

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 said :

"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... These trial results suggest that SAR236553/REGN727 may enable patients for whom statins are insufficient to further reduce LDL-C."

The main complaint from patients was irritation at the injection site, with four of them (one was on the placebo) developing a serious skin problem (leukocytoclastic vasculitis). In total, six from more than two hundred and fifty patients stopped the trials early due to adverse effects.

The PCSK9 mechanism is a good example of how studying genetics can identify new targets for developing ground-breaking therapies. PCSK9's role in lipid metabolism was only discovered a few years ago, based on population studies, and it now appears possible to target it directly to reduce cholesterol in a more effective manner.

President, Global Research & Development at Sanofi, Dr. Elias Zerhouni confirmed :

"Genetic data have shown that patients with natural loss-of-function mutations in PCSK9 have significantly lower LDL-C and a lower risk of coronary heart disease... Based on this finding and the results of our Phase 2 trials, Sanofi and Regeneron plan to initiate the SAR236553/REGN727 Phase 3 program in the second quarter."

Hypercholesterolemia, particularly an increase in LDL-C levels, is a major marker for cardiovascular disease, with arteries, especially those that supply the heart muscles with blood, becoming clogged with deposits. This new research represents an important step forward in counteracting the effects of high cholesterol.

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Section Issues On Medicine: Cardiology