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July 23, 2013
07:38 EDTARWRArrowHead begins phase 1 trial of ARC-520 for Hepatitis B infection treatment
Arrowhead Research announced that it has initiated dosing in a Phase 1 clinical trial of ARC-520, the company’s candidate for the treatment of chronic hepatitis B virus infection. Trial initiation followed successful completion of the Clinical Trial Notification regulatory process in Australia. The objectives of the study are to characterize the safety profile of ARC-520, determine maximum tolerated dose, and evaluate pharmacokinetics in healthy volunteers.The Phase 1 trial is a single-center, randomized, double-blind, placebo-controlled, single dose-escalation, first-in-human study of ARC-520 administered intravenously to healthy adult volunteers and is being conducted in Melbourne, Australia. Each dose cohort includes 6 subjects randomized at ratio of 1:2 to receive a single intravenous injection of either placebo or ARC-520. Arrowhead expects to complete this Phase 1 trial in Q4 and begin a Phase 2a trial in chronic HBV patients in 2014.
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May 5, 2015
07:43 EDTARWRArrowhead initiates transition to patients in Phase 1 ARC-AAT study
Arrowhead Research announced that it completed dosing healthy volunteers and will begin dosing patients in an on-going phase 1 study of ARC-AAT, the company’s clinical candidate for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency. AATD is a rare genetic disorder that can severely damage the liver and lungs of affected individuals. The study was designed to begin dose escalation in healthy volunteers and transition into patients when a predefined knockdown target is achieved. That target is at least 30% reduction of serum AAT levels in 3 subjects or greater than 60% reduction in a single subject. This was met during the third cohort. All three dose levels tested appear to be generally well tolerated and the data safety committee has cleared the study to move into patients with AATD. Dosing in patients may now begin at the highest dose level used in Part A and then continued dose escalation may proceed under the protocol. The company expects to complete the Phase 1 study by the end of 2015. The Phase 1 trial is a multi-center, randomized, placebo-controlled, double-blind, single dose-escalation first-in-human study to evaluate the safety, tolerability and pharmacokinetics of ARC-AAT and the effect on circulating AAT levels. The study has been enrolling in dose cohorts of six participants each, with participants randomized at a ratio of 2:1 to receive a single intravenous injection of either ARC-AAT or placebo. The study consists of two parts; Part A in healthy volunteers, which has been completed, and Part B to be conducted in patients with PiZZ genotype AATD. The study evaluates participants for 28 days following dosing, with additional follow-up if needed every 2 weeks until AAT levels return to baseline.
April 30, 2015
07:45 EDTARWRArrowhead publishes data on advances in subcutaneous siRNA delivery
Arrowhead Research announced the publication of new data on a subcutaneously administered formulation of its Dynamic Polyconjugate delivery system. The company believes the new DPCs are highly potent and may represent a dramatic improvement in duration of activity over competing technologies. This new class of DPCs may also enable targeting of RNAi therapeutics to tissues outside of the liver. The manuscript entitled, “Protease-triggered siRNA delivery vehicles,” by David B. Rozema et al, was made available online ahead of print in the Journal of Controlled Release 209 57-66. In the publication, Arrowhead scientists describe the development of protease-sensitive masking chemistries that are used in a class DPCs where the RNAi trigger molecule is conjugated directly to the polymer delivery vehicle. These new vehicles expand on the company’s existing acid labile DPCs, where the polymer and RNAi trigger are two separate molecules and are co-injected. The protease-sensitive linkages appear to be more stable and have longer circulation times, which may allow for an increased range of targeting, and appear amenable to subcutaneous administration. The publication reports a high level of target gene knockdown and long duration of effect can be achieved after subcutaneous injection with these new DPC delivery vehicles in nonhuman primates. After a single subcutaneous injection of 0.5 mg/kg siRNA against Factor 7, a liver expressed coagulation factor that is secreted into the bloodstream, a 99% reduction of FVII activity was observed in nonhuman primates. Further, this reduction was highly durable with maximal knockdown occurring 24 days after injection and measurable reduction in FVII activity appears to persist for up to 200 days.

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