Arrowhead Research Corporation (NASDAQ: ARWR), a
biopharmaceutical company developing targeted RNAi therapeutics,
presented data from a Phase 2a clinical study at The AASLD Liver
Meeting 2015® demonstrating that ARC-520, its lead drug
candidate against chronic hepatitis B infection (HBV), effectively
reduced HBV viral antigens derived from cccDNA. HBV surface antigen
(HBsAg) was reduced substantially with a maximum reduction of 1.9
logs (99%) and a mean maximum reduction of 1.5 logs (96.8%) in
treatment naïve e-antigen (HBeAg)-positive patients. This direct
antiviral effect was still evident 57 days after a single dose.
These data strongly support advancement of ARC-520, and Arrowhead
has initiated multiple studies aimed at producing a functional cure
of HBV.
Christopher Anzalone, Ph.D., Arrowhead’s president and chief
executive officer said, “At AASLD we presented data from our
clinical program and from a nonclinical study in chimpanzees. Both
of these studies show that ARC-520 can produce deep and durable
knockdown of HBV viral antigens. These data give us additional
confidence in the program as we move forward with multiple-dose and
combination studies of ARC-520, that we hope will lead to host
immune reconstitution, HBsAg seroclearance, and functional
cure.”
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, and
a principal investigator for Arrowhead’s Phase 2a clinical study,
delivered 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”.
In this presentation, Dr. Yuen and co-authors show that in the
Heparc-2001 clinical study, ARC-520 in combination with entecavir
achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and
core-related antigen (HBcrAg) of 1.9 logs (99%), 4.3 logs
(99.995%), 1.7 logs (98%), and 1.2 logs (93.7%), respectively.
HBeAg-positive, treatment naïve patients achieved consistent
reductions in HBsAg with a mean maximal reduction of 1.5 logs
(96.8%). ARC-520 caused a direct antiviral effect after a single
dose that was still evident after 57 days, which was the last
time-point available.
Consistent with findings from Arrowhead’s chimpanzee study, also
presented at AASLD, variations in viral antigen reduction indicated
that patients previously treated with chronic entecavir and
patients that were treatment-naive and negative for HBeAg likely
had lower levels of cccDNA derived mRNA transcripts. As such,
HBeAg-positive treatment naïve patients experienced a greater
relative reduction in HBsAg than patients that were HBeAg-negative
or treatment experienced. One transitional patient in cohort 7 was
HBeAg-positive at baseline and became HBeAg-negative at days 3 to
43. This patient experienced an intermediate response initially,
however HBsAg continued to trend downward through day 57, the last
time-point available.
In the clinical study, 58 patients with chronic HBV received
doses of 1mg/kg – 4 mg/kg of ARC-520 in 7 cohorts. The cohorts
varied by ARC-520 dose, HBeAg status, and prior NUC treatment
status. The primary objective of the study was to measure the depth
and duration of HBsAg reduction in response to a single dose or two
doses (cohort 6) of ARC-520 in combination with entecavir.
Arrowhead also assessed safety and tolerability and additional
secondary and exploratory endpoints.
ARC-520 was well tolerated with no serious adverse events (AE),
no dose limiting toxicities, no discontinuations due to medication
AEs, and a modest occurrence rate (23%) of AEs that were all deemed
unrelated to study drug by the principal investigator. No AE
occurred more than once. There were no AEs amongst 10 patients
receiving placebo. There was a low occurrence rate of abnormal
laboratory tests, with no observed relationship to timing or
dose.
Copies of presentation materials can be accessed by visiting the
Events section of the company’s website at
http://ir.arrowheadresearch.com/events.cfm.
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. Arrowhead is conducting Phase 2b multiple dose and
combination 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. To be added to the Company's email list and receive news
directly, please visit
http://ir.arrowheadresearch.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. 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.
Source: Arrowhead Research Corporation
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version on businesswire.com: http://www.businesswire.com/news/home/20151116005646/en/
Arrowhead Research CorporationVince Anzalone,
CFA626-304-3400ir@arrowres.comorInvestor Relations:The Trout
GroupChad Rubin646-378-2947ir@arrowres.comorMedia:Russo
PartnersMatt Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.com
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