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Alnylam Pharmaceuticals Inc And Collaborators Publish Clinical Trial Results With ALN-PCS, An RNAi Therapeutic Targeting PCSK9 For The Treatment of Hypercholesterolemia, In The Lancet


Thursday, 3 Oct 2013 08:00am EDT 

Alnylam Pharmaceuticals Inc announced the publication in The Lancet of complete study results from a Phase I trial with ALN-PCS, a systemically administered RNAi therapeutic targeting PCSK9 for the treatment of hypercholesterolemia. The paper, titled Effect of an RNA interference drug on the synthesis of proprotein convertase subtilisin/kexin type 9 (PCSK9) and the concentration of serum LDL cholesterol in healthy volunteers: a randomised, single-blind, placebo-controlled, phase 1 trial, (Fitzgerald, et al., The Lancet, doi:10.1016/S0140-6736(13)61914-5) reports the results of a study evaluating single intravenous dose administration of ALN-PCS, in the absence of concomitant lipid-lowering agents such as statins. Specifically, ALN-PCS administration resulted in a rapid, dose-dependent reduction in plasma PCSK9 of up to 84% relative to baseline and placebo, with a corresponding reduction in serum levels of low-density lipoprotein cholesterol (LDL-C) - a clinically validated endpoint - of up to 57% relative to baseline and placebo. The knockdown of PCSK9 and lowering of LDL-C were also found to be durable, with effects lasting for weeks after a single dose. This new paper documents the first human proof of concept for an RNAi therapeutic impacting a clinically validated endpoint. ALN-PCS is a systemically delivered RNAi therapeutic targeting PCSK9, a target validated by human genetics that is involved in the metabolism of LDL-C, or "bad" cholesterol. 

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