Arrowhead Pharmaceuticals Presents Promising ARC-520 Hepatitis B Data at The International Liver Congress™ 2016
April 13 2016 - 7:30AM
Business Wire
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced
that three presentations are being made on ARC-520, its
investigational medicine for the treatment of chronic hepatitis B
infection, at The International Liver Congress™ 2016 (ILC 2016), in
Barcelona, Spain, April 13-17, 2016.
Collectively, these presentations demonstrate several important
findings from Arrowhead’s clinical and nonclinical studies of
ARC-520, including the following:
- ARC-520 and entecavir produced rapid
HBV DNA suppression with all hepatitis B e-antigen (HBeAg)
positive, treatment naïve patients achieving serum HBV DNA
reductions of up to 5.5 log (99.9997%), and all HBeAg negative,
treatment naïve patients achieving reductions that put them below
the limit of quantitation
- ARC-520 effectively inhibited HBV
cccDNA-derived mRNA with observed viral protein reduction in HBV
patients of up to 2.0 log (99%) after a single dose
- Based on HBsAg epitope profile
analysis, poster authors and Arrowhead collaborators had previously
identified a predictive hepatitis B surface-antigen (HBsAg)
Clearance Profile associated with HBsAg clearance in antiviral
therapy cohorts
- There was a significant association
between the development of an HBsAg Clearance Profile and ARC-520
therapy in HBV patients
- Complexed HBsAg antibodies (anti-HBs)
were developed and detected in HBV patients treated with ARC-520,
which may represent a recovery of the immune system response
- After monthly administration of 6-11
doses of ARC-520 in chimpanzees chronically infected with HBV, the
ARC-520 target site sequences remained virtually unchanged,
indicating that no drug resistance developed during the treatment
period
Chris Anzalone, Ph.D., president and CEO of Arrowhead
Pharmaceuticals, said: “These are exciting results that
continue to show that ARC-520 can reduce the production of HBV
viral proteins. We have ongoing multiple-dose and combination
studies designed to assess if this will allow the body’s natural
immune defenses to control the virus and lead to a functional
cure.”
Copies of the poster presentations are currently available as
ePosters to ILC 2016 attendees, and we have also made them
available on the Arrowhead website on the Events and Presentations
page.
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, the most common reported adverse events
in all subjects completing treatment were upper respiratory
infection and headache.
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. The company’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 disorders, ARC-LPA for cardiovascular
disease, and ARC-HIF2 for renal cell carcinoma.
For more information please visit www.arrowheadpharma.com, or
follow us on Twitter @ArrowheadPharma. To be added to the Company's
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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 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.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead
Pharmaceuticals, Inc.
Source: Arrowhead Pharmaceuticals, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20160413005533/en/
Arrowhead Pharmaceuticals, Inc.Vince Anzalone,
626-304-3400CFAir@arrowheadpharma.comorInvestor
Relations:The Trout GroupChad Rubin,
646-378-2947ir@arrowheadpharma.comorMedia:Russo PartnersMatt
Middleman, 212-845-4272M.D.matt.middleman@russopartnersllc.com
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