Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV

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Arrowhead Pharmaceuticals Files...

PASADENA, Calif.–(BUSINESS WIRE)–

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it

filed a regulatory submission to begin a Phase 1/2 study of ARO-HBV,

which is being developed as a potentially curative therapy for patients

with chronic hepatitis B virus (HBV) infection. Pending approval,

Arrowhead intends to proceed with AROHBV1001, a Phase 1/2 single-dose

escalation study to evaluate the safety, tolerability, and

pharmacokinetic effects of ARO-HBV in healthy adult volunteers, as well

as a multiple-dose escalation study to evaluate the safety,

tolerability, and pharmacodynamic effects in HBV patients.

Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals,

said: “ARO-HBV is designed to silence all HBV gene products, including

transcripts from both cccDNA and integrated DNA. We believe ARO-HBV, as

a key component of combination therapies, may allow the body’s natural

immune defenses to control the virus and lead to a functional cure. The

clinical data that we recently presented at HEP DART 2017 indicate that

our prior generation compound, ARC-520, achieved a Sustained Host

Response in half of the previously treatment-naïve patients chronically

treated in that study, which we think bodes very well for ARO-HBV. The

regulatory filing announced today is substantially ahead of schedule and

we are excited to move into the clinic with multiple new compounds that

leverage our Targeted RNAi Molecule, or TRiMTM, platform

during 2018.”

The application for approval of the clinical trial was submitted to the

New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for

review by the Standing Committee on Therapeutic Trials (SCOTT), as well

as the local Ethics Committee.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable

diseases by silencing the genes that cause them. Using a broad portfolio

of RNA chemistries and efficient modes of delivery, Arrowhead therapies

trigger the RNA interference mechanism to induce rapid, deep, and

durable knockdown of target genes. RNA interference, or RNAi, is a

mechanism present in living cells that inhibits the expression of a

specific gene, thereby affecting the production of a specific protein.

Arrowhead’s RNAi-based therapeutics leverage this natural pathway of

gene silencing.

For more information, please visit www.arrowheadpharma.com,

or follow us on Twitter @ArrowheadPharma.

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please visit http://ir.arrowheadpharma.com/alerts.cfm.

Safe Harbor Statement under the Private Securities Litigation Reform

Act:

This news release contains forward-looking statements within the

meaning of the “safe harbor” provisions of the Private Securities

Litigation Reform Act of 1995. These statements are based upon our

current expectations and speak only as of the date hereof. Our actual

results may differ materially and adversely from those expressed in any

forward-looking statements as a result of various factors and

uncertainties, including the safety and efficacy of our product

candidates, the duration and impact of regulatory delays in our clinical

programs, our ability to finance our operations, the future success of

our scientific studies, our ability to successfully develop drug

candidates, the timing for starting and completing clinical trials,

rapid technological change in our markets, and the enforcement of our

intellectual property rights. Our most recent Annual Report on Form 10-K

and subsequent Quarterly Reports on Form 10-Q discuss some of the

important risk factors that may affect our business, results of

operations and financial condition. We assume no obligation to update or

revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
or
Investors

and Media:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com

Source: Arrowhead Pharmaceuticals, Inc.

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