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May 13, 2014
08:01 EDTALNYAlnylam announces results from ongoing phase 1 trial of ALN-AT3
Alnylam Pharmaceuticals announced top-line results from its ongoing Phase 1 trial of ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin in development for the treatment of hemophilia and rare bleeding disorders. These top-line results are being presented at the World Federation of Hemophilia 2014 World Congress being held May 11 – 15, 2014 in Melbourne, Australia. In Part A of the Phase 1 study, human volunteer subjects received a single subcutaneous dose of ALN-AT3 and, per protocol, the maximum allowable level of AT knockdown was set at 40%. Initial results show that a single, low subcutaneous dose of ALN-AT3 at 0.03 mg/kg resulted in an up to 28-32% knockdown of AT at nadir that was statistically significant relative to placebo. This led to a statistically significant increase in peak thrombin generation, that was temporally associated and consistent with the degree of AT knockdown. ALN-AT3 was found to be well tolerated with no significant adverse events reported. With these data, the company has transitioned to the Multiple Ascending Dose Part B of the study in moderate-to-severe hemophilia subjects. Consistent with previous guidance, the company plans to present initial clinical results from the Phase 1 study, including results in hemophilia subjects, by the end of the year. These human study results are the first to be reported for Alnylam’s Enhanced Stabilization Chemistry-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency, durability, and a wide therapeutic index. Further, these initial clinical results demonstrate a greater than 50-fold potency improvement with ESC-GalNAc conjugates relative to standard template chemistry conjugates.
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August 21, 2014
09:16 EDTALNYAlnylam to hold a roundtable webinar
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August 20, 2014
08:07 EDTALNYAlnylam receives USPTO notice of allowance for new patent
Alnylam Pharmaceuticals announced that the United States Patent and Trademark Office has issued a Notice of Allowance for claims in the Tuschl et al. patent application 13/725,262. The ’262 patent application includes newly allowed claims directed to compositions that mediate RNAi, and comprising a double-stranded molecule with up to 25 base pairs and at least one nucleotide analogue. Specifically, the newly allowed patent application broadly covers small interfering RNA molecules of various designs, including so-called “dicer substrate” RNAi triggers (Amarzguioui et al., Nat Protoc. 2006;1(2):508-17; Rose et al., Nucleic Acids Res. 2005 Jul 26;33(13):4140-56) and double-stranded, RNAi-mediating molecules containing moieties that include “unlocked nucleobase analogs” amongst other naturally or non-naturally occurring nucleotide analogues. The allowed claims of the Tuschl ’262 patent application, as well as other granted, Alnylam-owned or -licensed patents, in aggregate broadly cover compositions, methods, and uses of RNAi therapeutics.
August 19, 2014
15:50 EDTALNYAlnylam to hold a roundtable webinar
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August 14, 2014
07:24 EDTALNYAlnylam to hold a roundtable webinar
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August 13, 2014
06:29 EDTALNYAlnylam called at top mid-cap pick for second half at Piper Jaffray
Piper Jaffray calls Alnylam a top mid-cap pick for the second half of 2014 and reiterates an Overweight rating on the name with a $101 price target. Piper thinks shares can rally into 2015 based on data read-outs and pipeline expansion.
August 12, 2014
15:55 EDTALNYAlnylam to hold a roundtable webinar
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