We also presented clinical results from our ALN-AAT program showing potent, dose-dependent, and durable knockdown of the target protein, just as weve seen in clinical data presented from all of the other RNAi candidates in our pipeline to date. In this case, however, we observed a low incidence of asymptomatic, transiently elevated liver enzymes. We plan to advance a follow-on molecule in efforts to optimize the tolerability profile for this program, and we aim to file a CTA for ALN-AAT02 in 2017. We remain committed to developing RNAi therapeutics for alpha-1 liver disease, a rare genetic disease with significant unmet need where liver transplantation is the only treatment option beyond supportive care. New clinical data were presented from the Phase 1/2 trial of ALN-AAT, in which the safety and efficacy of ALN-AAT were evaluated in normal healthy volunteers, and are as of a data transfer date of June 30, 2016. In this study, subjects in Part A (N=20) were enrolled into 5 ascending dose groups (N=4 per group, randomized 3:1 drug:placebo), and received a single subcutaneous dose of ALN-AAT at doses ranging from 0.1 mg/kg to 6 mg/kg. Subjects in Part B (N=6, randomized 4:2 drug:placebo) received 4 doses of ALN-AAT at 1 mg/kg administered every 28 days. ALN-AAT administration resulted in potent, dose-dependent and durable knockdown of serum AAT. visit homepageA single 6 mg/kg dose of ALN-AAT attained an AAT knockdown of up to 88.9% with a mean maximal knockdown of 83.9 2.6%. The pharmacodynamic effects of ALN-AAT were highly durable, where a single dose at 6 mg/kg maintained mean AAT knockdown of 75.0 1.2% at approximately six months. ALN-AAT was shown to be generally well tolerated in healthy adult volunteers. There were no drug-related serious adverse events (SAEs), discontinuations due to adverse events (AEs), or injection site reactions reported.
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