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Home > Press > Arrowhead to Present Late-Breaking Analytic Abstracts on ARO-AAT and ARO-HBV at AASLD Alarmist Meeting® 2018

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Abstract:Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) will accomplish two late-breaking affiche presentations at The Alarmist Meeting® 2018, the Annual Meeting of the American Association for the Abstraction of Alarmist Ache (AASLD) actuality captivated on November 9-13, 2018, in San Francisco. The abstracts became accessible today on the Online Planner on the AASLD website.

ARO-HBV Presentation Details

First After-effects with RNA arrest (RNAi) in Abiding Hepatitis B (CHB) Using ARO-HBV

Publication Number: LB-25Session: Late-Breaking Affiche SessionSession Date and Time: November 12, 2018 from 8:00 AM to 5:30 PM PTLocation: Moscone Center North/South Building, Hall CAuthors: Dr. Edward J. Gane, et al.Abstract

Background: RNAi has apparent affiance as a abeyant basic of bound analysis for patients with abiding hepatitis B (CHB) based on its adeptness to blackout HBV mRNA thereby abbreviation all viral products, best conspicuously HBsAg. Analytic account has been bound by IV commitment and/or assurance concerns. ARO-HBV is composed of two siRNAs, anniversary anon conjugated to N-acetyl galactosamine to drive hepatocyte delivery. Administered subcutaneously (SQ), it is advised to blackout all mRNA from cccDNA and host chip viral DNA, afterwards charge for added commitment elements.

Methods: Normal advantageous advance (NHV) cohorts (4 active, 2 placebo) accustomed distinct SQ doses of 35, 100, 200, 300 or 400 mg. CHB cohorts 2b-5b (n=4, HBeAg pos or neg, NUC advised or not on NUCs) accustomed account doses x 3 of 100, 200, 300 or 400 mg. Cohorts of HBeAg pos, NUC naïve and accomplished CHB (cohorts 8, 9 respectively, n=4 each) are accepting 300 mg account x 3. NUC basic accept NUCs from day 1. After-effects appear are from 28 canicule afterwards 3rd dosage (day 85) back accessible or best recent.

Results: No austere AEs or dropouts in NHVs or CHBs accept been reported. AEs were balmy and agnate in accident for alive or placebo. Bang armpit AEs (all mild) action in ~11% of injections. For cohorts 2b-5b (n=16 active), 14 were BLQ for HBV DNA and 13 were HBeAg abrogating at baseline; 14 on abiding NUCs. In CHB, beggarly (max) log10 reductions in HBsAg were: 100 mg 2.0 (4.0) through Day 85, 200 mg 1.6 (2.2) through Day 85, 300 mg 1.5 (2.2) through Day 85 and 400 mg 1.7 (3.0) through day 71 in cohorts 2b-5b and 1.5 (3.0) in accomplice 8 through day 43 and 1.0 (1.3) through day 15 in accomplice 9. All patients extensive day 85 accept > 1.0 log10 abridgement in HBsAg with added HBsAg decreases empiric afterwards the additional and third doses. Of these 24 CHB, 21 had HBsAg >100 IU/ml at baseline and currently 17 accept accomplished HBsAg

Conclusions: ARO-HBV has been able-bodied acceptable in NHVs and CHB. ~11% of SQ injections were associated with balmy bang armpit AEs. Account RNAi with ARO-HBV finer reduces all assessable viral products, including HBsAg. ARO-HBV has characteristics adorable for RNAi to become a cornerstone analysis in bound regimens aimed at HBsAg approval in CHB.

ARO-AAT Presentation Details

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A Phase 1 Distinct and Assorted Dose-Escalating Abstraction to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect of ARO-AAT on Serum Alpha-1 Antitrypsin levels in Normal Adult Volunteers

Publication Number: LB-9Session: Late-Breaking Affiche SessionSession Date and Time: November 12, 2018 from 8:00 AM to 5:30 PM PTLocation: Moscone Center North/South Building, Hall CAuthors: Dr. Christian Schwabe, et al.Abstract

Background: Alpha-1 antitrypsin absence (AATD) is an autosomal co-dominant abiogenetic ataxia causing alarmist ache in accouchement and adults. Alpha-1 antitrypsin (AAT) is a glycoprotein produced primarily in hepatocytes. The PiZ alteration causes abnormal AAT folding and broken beard by hepatocytes arch to accession in the alarmist of AAT aggregates accepted as globules. Accumulated globules can advance to a alternate aeon of hepatic injury, fibrosis, cirrhosis and hepatocellular carcinoma. ARO-AAT is a hepatocyte targeted RNAi ameliorative advised to blackout assembly of Z-AAT protein with the absorbed of abbreviation alarmist globules. In a abrasion model, bargain alarmist Z-AAT amalgam activated to bargain serum AAT and bargain Z-AAT globules prevented progression and development of AATD-associated alarmist disease.

Methods: 45 advantageous volunteers (age 18-52) accustomed ascent distinct or assorted doses of ARO-AAT by subcutaneous injection. Capacity were randomized (4 placebo:4 active) to accept distinct 35 mg doses of ARO-AAT or placebo. Multi-dose cohorts (4 placebo:4 active) accustomed three doses every 28 canicule at doses of 100, 200 or 300 mg. In parallel, accessible characterization cohorts enrolled 4 capacity anniversary accepting a distinct dosage of ARO-AAT at 100, 200 and 300 mg to appraise distinct dosage continuance of response. Assessments included assurance (including pulmonary action tests), tolerability, pharmacokinetics, and pharmacodynamics. Capacity were evaluated through at atomic Day 29 (35 mg distinct dosage cohort) or Day 113 (open characterization and multi-dose cohorts) or until AAT levels alternate to 20% beneath baseline or aloft 90 mg/dL.

Results: No deaths, SAEs or astringent AEs accept been reported. The best accepted AEs were cephalalgia (22%) and rhinorrhea (13%). Distinct dosage serum AAT beggarly base reductions from baseline of 79%, 87%, >91% and >91% were appear at 35, 100, 200 and 300 mg respectively. Multi-dose beggarly base serum AAT reductions were >91% at all dosage levels with best capacity BLQ. Maximum AAT abridgement beyond all cohorts was >94%. A greater than 90% abridgement was abiding for at atomic 8 weeks afterward the aftermost dosage in the everyman multi-dose accomplice (100 mg), the alone accomplice with abstracts of this duration.

Conclusions: ARO-AAT has been able-bodied acceptable at doses as aerial as 300 mg accustomed three times every 28 days. Maximum base abridgement of >94% from baseline indicates almighty siRNA inhibition of hepatic AAT synthesis. Based on continuance of response, annual or beneath common dosing appears feasible.

A archetype of the presentation abstracts may be accessed on the Contest and Presentations folio beneath the Investors area of the Arrowhead website afterwards the presentations conclude.

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About Arrowhead Pharmaceuticals, Inc.Arrowhead Pharmaceuticals develops medicines that amusement awkward diseases by silencing the genes that account them. Using a ample portfolio of RNA chemistries and able modes of delivery, Arrowhead therapies activate the RNA arrest apparatus to abet rapid, deep, and abiding altercation of ambition genes. RNA interference, or RNAi, is a apparatus present in active beef that inhibits the announcement of a specific gene, thereby affecting the assembly of a specific protein. Arrowhead’s RNAi-based analysis advantage this accustomed alleyway of gene silencing.

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For added information, amuse appointment www.arrowheadpharma.com, or chase us on Twitter @ArrowheadPharma. To be added to the Company’s email account and accept account directly, amuse appointment http://ir.arrowheadpharma.com/email-alerts .

Safe Harbor Statement beneath the Private Securities Litigation Reform Act:

This account absolution contains advanced statements aural the acceptation of the “safe harbor” accoutrement of the Private Securities Litigation Reform Act of 1995. These statements are based aloft our accepted expectations and allege alone as of the date hereof. Our absolute after-effects may alter materially and abnormally from those bidding in any advanced statements as a aftereffect of assorted factors and uncertainties, including the assurance and adeptness of our artefact candidates, the continuance and appulse of authoritative delays in our analytic programs, our adeptness to accounts our operations, the approaching success of our accurate studies, our adeptness to auspiciously advance biologic candidates, the timing for starting and commutual analytic trials, accelerated abstruse change in our markets, and the administration of our bookish acreage rights. Our best contempo Annual Report on Form 10-K and consecutive Annual Reports on Form 10-Q altercate some of the important accident factors that may affect our business, after-effects of operations and banking condition. We accept no obligation to amend or alter advanced statements to reflect new contest or circumstances.

For added information, amuse bang here

Contacts:Arrowhead Pharmaceuticals, Inc.Vince Anzalone, CFA626-304-3400orInvestors and Media:LifeSci Advisors, LLCBrian Ritchie212-915-2578www.lifesciadvisors.com

Copyright © Arrowhead Pharmaceuticals, Inc.

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