Arrowhead Doses First Hepatitis B Patients in Multiple Dose Portion of Phase 1/2 Study of ARO-HBV

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Arrowhead Doses First Hepatitis...

PASADENA, Calif.–(BUSINESS WIRE)–May 14, 2018–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it
has dosed the first 3 hepatitis B virus (HBV) patients in the
multiple-ascending dose portion of its ongoing Phase 1/2 study of
ARO-HBV, the company’s third generation subcutaneously administered RNA
interference (RNAi) therapeutic being developed as a potentially
curative therapy for patients with chronic HBV infection. Arrowhead has
also dosed a total of 20 healthy volunteers (13 with ARO-HBV and 7 with
placebo) since the study began on March 27. The company intends to
submit a late-breaking abstract to present initial clinical data on
ARO-HBV, if accepted, at the Liver Meeting® 2018, the Annual
Meeting of the American Association for the Study of Liver Disease
(AASLD), being held in November. ARO-HBV leverages Arrowhead’s
proprietary Targeted RNAi Molecule (TRiM™) technology.

Bruce Given, M.D., chief operating officer and head of R&D at Arrowhead,
said, “Our Phase 1/2 study of ARO-HBV is designed to rapidly generate
meaningful readouts on safety, tolerability and pharmacologic activity.
The single-ascending dose and multiple-ascending dose phases are running
nearly in parallel, as opposed to sequentially, which has allowed dose
escalation and initiation of HBV patient dosing quickly. The results of
this study should provide us with insight into ARO-HBV as a potentially
important component of curative therapy for patients with chronic HBV
infection.”

AROHBV1001 (NCT03365947)
is a Phase 1/2 study evaluating the safety, tolerability, and
pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in
healthy adult volunteers, and evaluating the safety, tolerability, and
pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in
patients with chronic HBV.

The SAD portion is designed to include up to 5 cohorts of 6 subjects per
cohort. Each SAD subject will receive a single-dose administration of
either placebo or ARO-HBV at up to 5 dose levels (35, 100, 200, 300, 400
mg). The MAD portion is designed to include up to 8 cohorts of 4 HBV
patients per cohort. Each MAD patient will receive 3 doses of ARO-HBV at
up to 4 dose levels (100, 200, 300, 400 mg).

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.

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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
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uncertainties, including the safety and efficacy of our product
candidates, the duration and impact of regulatory delays in our clinical
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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
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and subsequent Quarterly Reports on Form 10-Q discuss some of the
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Source: Arrowhead Pharmaceuticals, Inc.

Source: Arrowhead Pharmaceuticals, Inc.

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