CAMBRIDGE, Mass. & PARSIPPANY, N.J.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics company, and The Medicines Company (Nasdaq:MDCO), a global biopharmaceutical company focusing on saving lives, alleviating suffering and contributing to the economics of healthcare by focusing on the world’s leading acute/intensive care hospitals, announced today that Alnylam has filed a Clinical Trial Application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 clinical trial with ALN-PCSsc, an investigational agent for the treatment of hypercholesterolemia. ALN-PCSsc is a subcutaneously administered RNAi therapeutic targeting the gene proprotein convertase subtilisin/kexin type 9 (PCSK9), a target validated by human genetics that is involved in the metabolism of low-density lipoprotein cholesterol (LDL-C, or “bad” cholesterol). Per the filed CTA, the Phase 1 trial of ALN-PCSsc will be conducted in the U.K. as a randomized, single-blind, placebo-controlled, single ascending- and multi-dose study, enrolling up to 76 volunteer subjects with elevated baseline LDL-C (= 100 mg/dL). Following approval of the CTA, the companies expect to initiate dosing in the Phase 1 trial in late 2014 or early 2015, with initial data expected to be reported in mid-2015.
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