Arrowhead Begins Dosing the Phase 2b MONARCH Combination Study of ARC-520 in Patients with Chronic Hepatitis B Infection

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Arrowhead Begins Dosing the Phase...

PASADENA, Calif.–(BUSINESS WIRE)–

Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical

company developing targeted RNAi therapeutics, dosed the first patient

in the Phase 2b MONARCH combination study of ARC-520, it’s RNAi-based

drug for the treatment of chronic hepatitis B virus (HBV) infection. The

clinical trial is currently enrolling patients at multiple centers in

Australia and New Zealand. MONARCH is intended to identify one or more

combinations of ARC-520 and other therapeutic agents that can

potentially lead to a functional cure of chronic HBV.

“We recently reported clinical data from our Phase 2a study at AASLD

showing that a single dose of ARC-520 can achieve a reduction of up to

99% in hepatitis B surface antigen, and nonclinical data at HepDART

showing that multiple doses of ARC-520 were associated with immune

reactivation in 7 of 9 chimpanzees studied. These data make us very

eager to see results as they emerge from MONARCH and our other multiple

dose studies,” said Christopher Anzalone, Ph.D., Arrowhead president and

CEO. “The goal of MONARCH is to identify one or more combinations of

ARC-520 and other agents that enable functional cures in patients. If we

can achieve this, it would represent a big leap forward in the field and

provide hope for the more than 350 million people worldwide chronically

infected with the hepatitis B virus.”

The MONARCH study, also called Heparc-2008, is a multicenter, open-label

study to evaluate ARC-520 administered alone and in combination with

other therapeutics in patients with chronic hepatitis B virus infection.

The primary outcome measure is the percentage of patients achieving a

1-log reduction in hepatitis B surface antigen (HBsAg) compared to

baseline. Secondary outcome measures include the percentage of patients

achieving HBsAg loss and time to HBsAg loss based on qualitative assay,

percentage of patients achieving anti-HBs seroconversion and time to

anti-HBs seroconversion (antibody to HBsAg), percentage of patients

achieving a 1-log reduction in HBsAg and achieving a HBsAg level less

than 100 IU/L, as well as other outcome measures.

The initial six cohorts are each planned to consist of up to twelve

treatment naïve patients. Patients in cohort 1 will receive ARC-520 as

monotherapy once every 4 weeks for 48 weeks (13 doses). Patients in

cohorts 2-6 will be stratified by e-antigen status and HBV genotype.

They will receive the same regimen of ARC-520 for 48 weeks in

combination with daily entecavir for 60 weeks and pegylated interferon

alpha 2a (PEG IFN) for 48 weeks. MONARCH is designed to allow for new

cohorts to be added that test additional dosing regimens and different

combinations as new agents become available for study.

About ARC-520

Arrowhead’s RNAi-based candidate ARC-520 is being investigated in the

treatment of chronic HBV infection. The small interfering RNAs (siRNAs)

in ARC-520 intervene at the mRNA level, upstream of the reverse

transcription process where current standard of care nucleotide and

nucleoside analogues act. Arrowhead is investigating ARC-520

specifically to determine if it can be used to achieve a functional

cure, which is an immune clearant state characterized by hepatitis B

s-antigen negative serum with or without seroconversion. Approximately

350-400 million people worldwide are chronically infected with the

hepatitis B virus, which can lead to cirrhosis of the liver and is

responsible for 80% of primary liver cancers globally. Arrowhead is

currently conducting Phase 2b multiple dose and combination studies in

chronic HBV patients. In clinical studies to date, there have been no

serious or severe adverse events (AEs), no dose limiting toxicities, no

discontinuations due to AEs, and a modest overall occurrence rate of AEs

without a clear dose-related increase in frequency or severity. The most

common reported AEs in all subjects completing treatment to date were

upper respiratory infection and headache.

About Arrowhead Research Corporation

Arrowhead Research Corporation is a biopharmaceutical company developing

targeted RNAi therapeutics. The company is leveraging its proprietary

Dynamic Polyconjugate™ delivery platform to develop targeted

drugs based on the RNA interference mechanism that efficiently silences

disease-causing genes. Arrowhead’s pipeline includes ARC-520 and ARC-521

for chronic hepatitis B virus, ARC-AAT for liver disease associated with

alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and

thromboembolic diseases, and ARC-HIF2 for renal cell carcinoma.

For more information please visit http://www.arrowheadresearch.com,

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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

results may differ materially and adversely from those expressed in any

forward-looking statements as a result of various factors and

uncertainties, including 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

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Corporation.

Source: Arrowhead Research Corporation

Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor

Relations:
The Trout Group
Chad Rubin
646-378-2947
ir@arrowres.com
or
Media:
Russo

Partners
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Source: Arrowhead Research Corporation

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