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Biologics inch toward cholesterol-lowering market

Nature Biotechnology volume 30, pages 302–303 (2012)Cite this article

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In the clinic, PCSK9 inhibition is rapidly gaining traction as it is backed by studies showing dramatic reductions in circulating cholesterol. In preliminary phase 2 data reported last November at the American Heart Association's annual scientific sessions, Regeneron's fully human PCSK9-blocking antibody achieved a 65% mean drop in LDL levels in individuals with familial hypercholesterolemia after just three treatments at the high dose. In a second trial enrolling 90 individuals with non-familial hypercholesterolemia, those treated with statins and anti-PCSK9, saw LDL levels plummet a further 65% on top of the statin benefit. Regeneron developed the PCSK9 mAb in partnership with Paris-based Sanofi, using Regeneron's VelocImmune mice, in which their murine variable chain regions have been removed and replaced with human heavy- and light-chain counterparts. Amgen of Thousand Oaks, California, has reported similarly dramatic LDL reductions for its antibody in phase 1, and Alnylam Pharmaceuticals in Cambridge, Massachusetts, reported in January that its lipid nanoparticle siRNA therapeutic in phase 1 led to a mean reduction in LDL of 39% after a single dose.

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  1. Ann Arbor, Michigan

    Ken Garber

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  1. Ken Garber
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Garber, K. Biologics inch toward cholesterol-lowering market. Nat Biotechnol 30, 302–303 (2012). https://doi.org/10.1038/nbt0412-302

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