Alnylam Pharmaceuticals, Inc. (ALNY) intends to file a clinical trial application (CTA) for ALN-CC5 by year end. ALN-CC5 is a subcutaneously administrated ribo nucleic acid interference (RNAi) therapeutic targeting the complement component C5.
The candidate is being developed for the treatment of complement-mediated diseases. The company has plans to announce initial study results in mid-2015.
Alnylam announced encouraging new pre-clinical results on ALN-CC5. Results were reported from non-human primate (NHP) studies which evaluated the candidate (once monthly) and also from a rodent model of primary membranous nephropathy.
The candidate showed potent and clamped C5 knockdown and robust inhibition of complement activity for up to 100 days. ALN-CC5 also showed a reduction in proteinuria due to complement-mediated disease activity in the kidney.
We are encouraged by Alnylam’s progress with its RNAi therapeutics. Presently, the two most advanced candidates at Alnylam are Patisiran and ALN-TTRsc. While Patisiran is in a phase III study for the treatment of transthyretin -mediated Amyloidosis (ATTR) patients suffering from familial amyloidotic polyneuropathy, ALN-TTRsc is in a phase III study for the treatment of ATTR patients suffering from cardiac amyloidosis.
Alnylam is yet to have an approved product. With most of its candidates either in the early or mid-stages of development, we expect investor focus to remain on the company’s pipeline. Any hiccups in pipeline development will weigh heavily on the stock.
Alnylam carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Gilead Sciences Inc. (GILD), Medivation, Inc. (MDVN) and Biogen Idec Inc. (BIIB). All these stocks hold a Zacks Rank #1 (Strong Buy).
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