Arrowhead Presents ARC-520 and ARC-521 Clinical Data at The International Liver Congress™

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Arrowhead Presents ARC-520 and...

PASADENA, Calif.–(BUSINESS WIRE)–

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented clinical

data from a Phase 2 study of ARC-520 and a Phase 1/2 study of ARC-521,

the company’s prior generation investigational medicines that were being

studied for the treatment of chronic hepatitis B virus (HBV) infection,

at The International Liver Congress™ 2017 (ILC), the annual meeting of

the European Association for the Study of the Liver (EASL).

Together, these presentations demonstrate that in human clinical

studies, RNAi interference (RNAi) as a mechanism can rapidly and

significantly reduce HBV viral antigens. In addition, RNAi appears to

synergize with current standard-of-care nucleotide and nucleoside

analogues (NUCs) to rapidly lower serum levels of HBV DNA. Arrowhead is

currently developing ARO-HBV, a follow-on product candidate that

utilizes the company’s next generation, proprietary subcutaneously

administered delivery vehicle, as a potentially curative therapy for

patients with chronic hepatitis B infection.

Bruce Given, M.D., chief operating officer, head of R&D for Arrowhead

Pharmaceuticals, said: “Arrowhead’s ARC-520 and ARC-521 clinical studies

have generated important data that continue to inform and guide the

development path of ARO-HBV, our follow-on candidate against chronic

HBV. We saw reductions in hepatitis B surface antigen, or HBsAg, of up

to 3 logs following multiple doses with ARC-520 in combination with a

NUC. HBV DNA was reduced by several logs and became undetectable in many

patients. In addition, early data from the ARC-521 study indicate that

RNAi therapeutics can be active against HBV gene products derived from

both cccDNA and integrated HBV DNA. These data are consistent with

findings from a long-term study in chimpanzees that we reported on

previously. We view these results as validation for the use of RNAi in

HBV, and believe ARO-HBV has the potential to serve as a cornerstone

therapy for combinations intended to cure chronic HBV.”

Presentation materials can be accessed by visiting the Events

section of the Arrowhead website. Additional details including abstracts

can be found on the ILC website at https://ilc-congress.eu/

by searching for the following:

Oral Presentation:

Prolonged RNA interference therapy with ARC-520 Injection in

treatment naïve, HBeAg positive and negative patients with chronic HBV

results in significant reductions of HBs antigen

  • Presentation Reference: PS-045

  • Session: Parallel session: Hepatitis B and D: Emerging treatment

    options

  • Date and Time: April 20, 2017 at 5:30 PM CET

  • Authors: Man-Fung Yuen, et al.

Poster Presentation:

A phase 1 study to evaluate safety and tolerability of escalating

single doses of the HBV RNA interference drug ARC-521 in a healthy

volunteer population

  • Presentation Reference: THU-176

  • Session: Viral hepatitis: Hepatitis B and D – Clinical (therapy, new

    compounds, resistance)

  • Session Date and Time: April 20, 2017 from 8:00 AM to 6:00 PM CET

  • Authors: Edward Gane, et al.

Arrowhead announced on November 29, 2016 that it had discontinued

development of ARC-520, ARC-521. The company continues to develop

ARO-HBV, which is a follow on investigational RNAi therapeutic against

chronic HBV that utilizes the company’s next generation, proprietary

subcutaneously administered delivery vehicle.

The International Liver Congress is a trademark of the European

Association for the Study of the Liver.

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
Matthew P. Duffy,

212-915-0685
matthew@lifesciadvisors.com

Source: Arrowhead Pharmaceuticals Inc.

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