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Sanofi-Regeneron cholesterol drug could be an alternative to statins

Positive trial results put the novel drug for patients with genetic cholesterol disorder on course for phase III

An investigational cholesterol drug from Sanofi and Regeneron is to enter phase III development after demonstrating it could lower bad cholesterol levels in difficult-to-treat patients.

Phase II trials of the treatment, currently known as SAR236553/REGN727, showed a reduction from baseline in a patient's levels LDL cholesterol of 28.9 per cent to 67.9 per cent compared to a reduction of just 10.7 per cent in patients taking placebo.

The results are a positive step for Sanofi, with the antibody looking increasingly like it could be a viable alternative for patients who are unable to control cholesterol levels through use of other treatments such as statins, which can actually stimulate the production of PCSK9.

The new study, published in The Lancet, involved 77 patients with heterozygous familial hypercholesterolemia (HeFH) – a genetic disorder that is characterised by the presence of ineffective receptors for LDL cholesterol, leading to a build up of substance, and which affects about 1 in 500 people.

Sanofi and Regeneron's injectable antibody is designed to work by targeting the PCSK9 protein, which aids the degradation of the LDL receptors when it binds onto them.

SAR236553/REGN727 inhibits the action of PCSK9, however, meaning there should be a greater number of LDL receptors free to remove excess LDL cholesterol from the blood.

“There remains a high degree of unmet need in [HeFH] patients as a large percentage are unable to reach optimal LDL-C goals despite being on maximal lipid-lowering therapy,” said Dr Evan Stein, director of the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio, and principal investigator of the study.

“These data suggest that SAR236553/REGN727 may provide a new option, on top of existing therapies, to lower LDL cholesterol and finally reach LDL-C goals for these difficult-to-treat patients.”

Sanofi said it intends to initiate phase III investigations in June, 2012 and mean the drug is pushing further ahead of rival PCSK9 inhibitor AMG 145 from Amgen, which is still in phase II.

Other companies active in the area include Bristol-Myers Squibb and Merck & Co, which have early-stage candidates in development.

28th May 2012

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