PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today announced that
additional clinical data on ARC-520, its RNAi therapeutic candidate for
the treatment of chronic hepatitis B infection, will be presented in the
late-breaking poster session at The Liver Meeting® 2015, the
66th Annual Meeting of the American Association for the Study of Liver
Disease (AASLD) being held on November 13-17, 2015, in San
Francisco.
The late-breaking abstract details results from the Heparc-2001, Phase 2
study of ARC-520 in combination with entecavir (ETV). Key findings
include the following:
-
Naïve patients reduced viral DNA up to 4.3 log (mean 2.2 log)
-
Naïve e-antigen (HBeAg) positive patients reduced surface antigen
(HBsAg) up to 1.9 log (mean max 1.1 log)
-
ARC-520 reduced HBeAg up to 1.7 log (mean max 1.2 log)
-
ARC-520 therapy was well tolerated with no adverse events rated
serious, severe, drug-related or causing withdrawal from the trial
-
15 patients are continuing in follow-up and additional results may
be available to report at The Liver Meeting
Christopher Anzalone, Ph.D., president and CEO of Arrowhead,
said, “In the Phase 2 study, ARC-520 effectively inhibited
cccDNA-derived mRNA with protein knockdown up to 99% or 1.9 logs
observed. This is the highest knockdown ever reported using RNAi in
humans. Our clinical program and our study in chronically infected
chimps continue to teach us a lot about HBV and we are thrilled to get
the opportunity to make three presentations at The Liver Meeting next
month.”
With the addition of the late-breaking poster, Arrowhead has the
following three abstracts accepted for presentation at the Liver Meeting:
November 15, 3:15 p.m. PST – Christine Wooddell, Ph.D., group
leader will deliver an oral presentation titled, “Reductions in
cccDNA under NUC and ARC-520 therapy in chimpanzees with chronic
hepatitis B virus infection implicate integrated DNA in maintaining
circulating HBsAg”
November 16, 8:00 a.m. – 5:30 p.m. PST – Man-Fung Yuen, M.D.,
Ph.D., chair of gastroenterology and hepatology, The University of Hong
Kong, and deputy chief of service, Queen Mary Hospital department of
medicine, Hong Kong, will deliver a late-breaking poster presentation
titled, “ARC-520 produces deep and durable knockdown of viral
antigens and DNA in a phase II study in patients with chronic hepatitis B”
November 17, 8:00 a.m. – 12:00 p.m. PST – Christine Wooddell,
Ph.D., group leader will deliver a poster presentation titled, “Monthly
dosing of ARC-520 in chronically hepatitis B virus infected chimpanzees
produces rapid, deep and durable reductions in circulating viral antigens”
Additional details including presentation abstracts can be found on the AASLD
website by clicking this link. A copy of presentation materials can
be accessed by visiting the Events
section of the Arrowhead website after the presentations conclude.
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 sero-conversion. Arrowhead has
completed a Phase 1 single ascending dose study in normal volunteers and
the company is conducting single dose Phase 2a studies and multiple dose
Phase 2b studies in chronic HBV patients. 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.
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,
or follow us on Twitter @ArrowRes.
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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 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. 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
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.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research
Corporation.
The Liver Meeting is a registered trademark of the American
Association for the Study of Liver Disease.
Source: Arrowhead Research Corporation
View source version on businesswire.com: http://www.businesswire.com/news/home/20151020005585/en/
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
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
Source: Arrowhead Research Corporation
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