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
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of our intellectual property rights. Arrowhead Research Corporation's
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
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Source: Arrowhead Research Corporation
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