SYDNEY, Feb. 16, 2017
/PRNewswire/ -- Benitec Biopharma Limited (ASX: BLT; NASDAQ:
BNTC; NASDAQ: BNTCW) today announced that it will present pivotal
data from the Company's hepatitis B virus (HBV) in vivo
model at the 26th Conference of the Asian Pacific
Association for the Study of the Liver (APASL) meeting, in
Shanghai China. Dr David
Suhy, Benitec's Chief Scientific Officer will detail the expanded
data set during an oral presentation entitled, 'Combinations of a
DNA-directed RNA interference Agent with Standard of Care Drugs
Results in Superior Suppression of Hepatitis B Virus (HBV) in a
Chimeric Mouse Model.'
Data presented at leading liver conference
This is the first public forum where Benitec will present the
expanded data set from the chimeric mouse study results that were
initially reported in December 2016.
The data demonstrate that a single administration of one of
three DNA-directed RNA interference (ddRNAi) agents, BB-101, BB-102
or BB-103, used in combination with current standard of care agents
used to treat HBV, demonstrates significantly robust and sustained
suppression of the disease in an in vivo model.
The APASL conference is an annual event hosted by one of the
world's leading associations for the investigation and treatment of
liver disease.
A single administration of a ddRNAi agent substantially
enhances HBV suppression when used in combination with antiviral
agents
This in vivo study assessed the activity of single doses
of ddRNAi therapeutic constructs BB-101, BB-102 and BB-103 in the
PhoenixBio mouse model, in which a substantial portion of the mouse
liver cells have been replaced with human hepatocytes making the
animals susceptible to HBV infection.
As previously reported in December
2016, when dosed individually in the absence of other
anti-viral drugs, a single dose of BB-103 or BB-102 resulted in
corresponding maximum drop of serum HBV DNA levels at 2.17 log and
1.87 log reduction. A modest rebound of HBV DNA levels were noted
following 56 days of treatment. A treatment arm consisting only of
daily entecavir resulted in a 2.63 log drop in serum HBV DNA
levels. In combination with daily entecavir, a single dose of
BB-103 and BB-102 dropped the serum HBV DNA levels below 3.72 log,
the lower limit of quantification (LLOQ) for the assay. The
LLOQ represents the lowest value that can result in accurate
quantification of HBV DNA levels. Although HBV DNA is detectable
below this level, it cannot be quantified. The reduction in
viral burden continued to diminish until the end of the 91 day
experiment with these combinations. In addition, BB-103 plus
entecavir and BB-102 plus entecavir also dropped HBsAg levels, a
known contributor to immunosuppression and HBV chronicity, by 2.14
log and 1.86 log. In comparison, treatment with entecavir
only dropped HBsAg levels by 0.46 log.
Expanded results from preclinical model demonstrates
potential for new treatment options
Benitec's Chief Scientific Officer, Dr. David Suhy said, "It is likely that a
combination of drugs will be required to successfully treat the
majority of subjects infected with HBV. The ability to apply
constant, therapeutic pressure at multiple points within the life
cycle of the virus by using a wide variety of drugs is a well
established treatment modality for treating many infectious
diseases. Thus, there is a race to determine which of the new types
of therapeutics being developed can be successfully combined with
established drugs to treat HBV. We believe the data being
presented, a one time treatment on top of existing therapies,
offers a compelling case for the inclusion of a ddRNAi therapeutic
into the treatment regimen."
New data helps guide Benitec team for clinical protocol
design
In addition to co-treatment with nucleoside analogues, this
current study tested combinations of either BB-101, BB-102 or
BB-103 when co-administered with pegylated interferon which
resulted in a significant decrease in HBV serum DNA levels at 2.67,
2.78 and 3.27 log respectively. This modest drop, as compared
to 2.41 log drop from interferon treatment alone, potentially
suggests that the mechanism of action of interferon may obstruct or
impair the ability of the natural cellular machinery to induce RNA
interference.
Georgina Kilfoil, Benitec's Chief
Clinical Officer commented, "The results of these experiments will
help guide the development of the clinical protocol for the first
in man clinical trials of this ddRNAi treatment modality.
Clearly co-administration with a nucleoside analogue such as
entecavir is useful in the overall treatment regimen, while other
therapeutic combinations may be less effective."
Benitec's ddRNAi technology is a unique combination of gene
silencing using RNA interference coupled with the long term
therapeutic activity of gene therapy vectors. For the HBV program,
the lead candidates are comprised of an adeno associated virus
capsid (AAV8) and a recombinant DNA cassette engineered to express
steady state levels of three short hairpin RNA (shRNA) that inhibit
HBV viral RNA at three regions well conserved across all major
genotypes.
The full presentation for the APASL meeting is posted on the
company's webpage at www.benitec.com.
For further information regarding Benitec and its activities,
please contact the persons below, or visit the Benitec website at
www.benitec.com
Australia
Investor Relations
|
United States
Investor Relations
|
Market Eye
Orla
Keegan
Director
Tel: +61 (2) 8097
1201
Email:
orla.keegan@marketeye.com.au
|
M Group Strategic
Communications
Jay
Morakis
Managing
Director
Tel: +1
212.266.0190
Email:
jmorakis@MGroupSC.com
|
About Benitec Biopharma Limited:
Benitec
Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is a
biotechnology company developing innovative therapeutics based on
its patented gene-silencing technology called ddRNAi or 'expressed
RNAi'. Based in Sydney, Australia
with laboratories in Hayward,
California (USA), and collaborators and licensees around the
world, the company is developing ddRNAi-based therapeutics for
chronic and life-threatening human conditions including hepatitis
B, wet age-related macular degeneration and OPMD. Benitec has also
licensed ddRNAi to other biopharmaceutical companies for
applications including HIV/AIDS, Huntington's Disease, chronic
neuropathic pain, cancer immunotherapy and retinitis
pigmentosa.
About Hepatitis B: Worldwide, 2 billion people (1 out of
3 people) have been infected with hepatitis B virus (HBV) and 400
million people have become chronically infected, including 1 to 2
million people in the United
States. An estimated 1 million people die each year from
hepatitis B and its complications worldwide; about 5,000 of those
are in the U.S. Worldwide, chronic infection with hepatitis causes
80% of all hepatocellular carcinoma (HCC) and more than 500,000
people die each year from this lethal cancer. About 5% of the
population are chronic carriers of HBV, and nearly 25% of all
carriers develop serious liver diseases such as chronic hepatitis,
cirrhosis, and HCC. Current treatment options include long-term
antiviral therapies that permit low-levels of virus cells to
replicate leading to HBV viral persistence and affecting
therapeutic outcomes. There is a significant need for safe and
convenient novel therapeutics that restore host immune response
through targeted HBsAg knockdown offering HBV patients the
potential for 'functional cures' by eliminating virus producing
cells.
Safe Harbor Statement:
This press release
contains "forward-looking statements" within the meaning of section
27A of the US Securities Act of 1933 and section 21E of the US
Securities Exchange Act of 1934. Any forward-looking statements
that may be in the press release are subject to risks and
uncertainties relating to the difficulties in Benitec's plans to
develop and commercialise its product candidates, the timing of the
initiation and completion of preclinical and clinical trials, the
timing of patient enrolment and dosing in clinical trials, the
timing of expected regulatory filings, the clinical utility and
potential attributes and benefits of ddRNAi and Benitec's product
candidates, potential future out-licenses and collaborations, the
intellectual property position and the ability to procure
additional sources of financing. Accordingly, you should not rely
on those forward-looking statements as a prediction of actual
future results.
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SOURCE Benitec Biopharma Limited