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April 28, 2014
11:58 EDTALNYAlnylam updates increase confidence in upcoming data, says Piper Jaffray
After Alnylam presented new data on its Phase II study of patisiran in patients with Familial Amyloidotic Polyneuropathy, PiperJaffray says that the data increases its optimism about the outlook for a Phase III trial of the treatment in 2016. The firm keeps an Overweight rating on the stock.
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November 11, 2015
10:46 EDTALNYAlnylam and The Medicines Co. reports trial results with ALN-PCSsc
Alnylam (ALNY) and The Medicines Company (MDCO) reported results from their ongoing Phase 1 clinical trial with ALN-PCSsc in an oral presentation at the American Heart Association Scientific Sessions 2015. ALN-PCSsc is an investigational RNAi therapeutic targeting PCSK9 - a genetically validated protein regulator of LDL receptor metabolism - being developed for the treatment of hypercholesterolemia. As reported previously, subcutaneous administration of ALN-PCSsc resulted in an up to 83% lowering of LDL-C, with an up to 64 +/- 5 percent mean maximum reduction, comparable to published results for anti-PCSK9 MAbs. In new results, the effects of ALN-PCSsc were found to be highly durable, with clinically significant and clamped reductions in LDL-C, supportive of a potential bi-annual subcutaneous dose regimen. Specifically, an up to 53 percent maximal and 47% least squares mean reduction in LDL-C was achieved at day 180 after just a single, low volume injection. In addition, ALN-PCSsc was shown to reduce a number of atherogenic lipids, including lipoprotein - or "Lp" - and total cholesterol, which are associated with increased risk of cardiovascular disease. ALN-PCSsc was generally well tolerated with no clinically significant drug-related adverse events. The development leadership of ALN-PCSsc has now transferred from Alnylam to The Medicines Company, who expects to initiate the ORION-1 Phase 2 study by the end of 2015.

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