PASADENA, Calif.--(BUSINESS WIRE)--
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented clinical
data from a Phase 2 study of ARC-520 and a Phase 1/2 study of ARC-521,
the company's prior generation investigational medicines that were being
studied for the treatment of chronic hepatitis B virus (HBV) infection,
at The International Liver Congress™ 2017 (ILC), the annual meeting of
the European Association for the Study of the Liver (EASL).
Together, these presentations demonstrate that in human clinical
studies, RNAi interference (RNAi) as a mechanism can rapidly and
significantly reduce HBV viral antigens. In addition, RNAi appears to
synergize with current standard-of-care nucleotide and nucleoside
analogues (NUCs) to rapidly lower serum levels of HBV DNA. Arrowhead is
currently developing ARO-HBV, a follow-on product candidate that
utilizes the company's next generation, proprietary subcutaneously
administered delivery vehicle, as a potentially curative therapy for
patients with chronic hepatitis B infection.
Bruce Given, M.D., chief operating officer, head of R&D for Arrowhead
Pharmaceuticals, said: "Arrowhead's ARC-520 and ARC-521 clinical studies
have generated important data that continue to inform and guide the
development path of ARO-HBV, our follow-on candidate against chronic
HBV. We saw reductions in hepatitis B surface antigen, or HBsAg, of up
to 3 logs following multiple doses with ARC-520 in combination with a
NUC. HBV DNA was reduced by several logs and became undetectable in many
patients. In addition, early data from the ARC-521 study indicate that
RNAi therapeutics can be active against HBV gene products derived from
both cccDNA and integrated HBV DNA. These data are consistent with
findings from a long-term study in chimpanzees that we reported on
previously. We view these results as validation for the use of RNAi in
HBV, and believe ARO-HBV has the potential to serve as a cornerstone
therapy for combinations intended to cure chronic HBV."
Presentation materials can be accessed by visiting the Events
section of the Arrowhead website. Additional details including abstracts
can be found on the ILC website at https://ilc-congress.eu/
by searching for the following:
Prolonged RNA interference therapy with ARC-520 Injection in
treatment naïve, HBeAg positive and negative patients with chronic HBV
results in significant reductions of HBs antigen
Presentation Reference: PS-045
Session: Parallel session: Hepatitis B and D: Emerging treatment
Date and Time: April 20, 2017 at 5:30 PM CET
Authors: Man-Fung Yuen, et al.
A phase 1 study to evaluate safety and tolerability of escalating
single doses of the HBV RNA interference drug ARC-521 in a healthy
Presentation Reference: THU-176
Session: Viral hepatitis: Hepatitis B and D - Clinical (therapy, new
Session Date and Time: April 20, 2017 from 8:00 AM to 6:00 PM CET
Authors: Edward Gane, et al.
Arrowhead announced on November 29, 2016 that it had discontinued
development of ARC-520, ARC-521. The company continues to develop
ARO-HBV, which is a follow on investigational RNAi therapeutic against
chronic HBV that utilizes the company's next generation, proprietary
subcutaneously administered delivery vehicle.
The International Liver Congress is a trademark of the European
Association for the Study of the Liver.
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
For more information, please visit www.arrowheadpharma.com,
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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 the safety and efficacy of our product
candidates, the duration and impact of regulatory delays in our clinical
programs, 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.
Source: Arrowhead Pharmaceuticals, Inc.
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Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
LifeSci Advisors, LLC
Matthew P. Duffy,
Source: Arrowhead Pharmaceuticals Inc.
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