Arbutus Announces ARB-1467 Data Presentation at EASL
April 22 2017 - 4:00AM
ARB-1467 Reduces Serum HBsAg in Both HBeAg
Negative and HBeAg Positive PatientsResults of Biweekly Dosing from
Cohort 4 Expected in 3Q17Additional Study Starting in 2H17 to
Evaluate Longer Term Dosing with Immune Modulatory Agents
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading
Hepatitis B Virus (HBV) therapeutic solutions company, presented
results of the first three cohorts of a Phase II study of its RNAi
agent, ARB-1467, at the European Association for the Study of the
Liver (EASL) in Amsterdam, The Netherlands.
“We are very pleased to present updated Phase II
results for ARB-1467 that show a consistent reduction in HBsAg in
HBV patients regardless of HBeAg status with a favorable safety
profile. We look forward to a 3Q17 announcement of the results of
Cohort 4, which is evaluating five bi-weekly doses of ARB-1467 with
extended monthly dosing out to one year for patients who meet
predefined response criteria,” said Dr. Mark J. Murray, Arbutus’
President and CEO. “Furthermore, we are planning to initiate a new
study of ARB-1467 in 2H17 to evaluate longer dosing of ARB-1467
combined with immunomodulatory agent. We believe that this study
could pave the way for Phase IIb studies while we continue to
advance the rest of our pipeline to enable new treatment regimens
for further improvement in clinical outcomes.”
The presentation is titled "A Phase 2a Study
Evaluating the Multi-Dose Activity of ARB-1467 in HBeAg Positive
and Negative Virally Suppressed Subjects with Hepatitis B", and a
copy of the poster can be accessed by visiting the Investor section
of www.arbutusbio.com and selecting ‘Events and Presentations.’
Cohort |
ARB-1467 (mg/kg) |
HBeAg |
Single Dose HBsAg
Reduction (log10 IU/mL) |
Multiple Dose HBsAg Reduction
(log10 IU/mL) |
N |
Meana |
Mean Maxb |
Maxc |
N |
Meana |
Mean Maxb |
Maxc |
>0.5 logd |
>1.0 logd |
1 |
0.2 |
Neg |
6 |
-0.3 |
-0.4 |
-1.0 |
6 |
-0.6 |
-0.7 |
-1.3 |
5 |
1 |
2 |
0.4 |
Neg |
6 |
-0.2 |
-0.3 |
-0.8 |
5e |
-0.8 |
-0.9 |
-1.1 |
4 |
3 |
3 |
0.4 |
Pos |
6 |
-0.2 |
-0.3 |
-0.6 |
6 |
-0.7 |
-0.8 |
-1.6 |
4 |
2 |
Placebo |
|
All |
6f |
0.0 |
0.0 |
-0.1 |
6 |
0.0 |
-0.1 |
-0.1 |
0 |
0 |
a The mean serum HBsAg reduction is the nadir
value of the arithmetic mean of all values observed at each time
point.b The mean maximum HBsAg reduction is the mean of each
patient’s maximum reduction in serum HBsAg. c Maximum HBsAg
reduction is the best single reduction among all patients in a
cohort.d Number of patients reaching this thresholde Multiple dose
results in Cohort 2 exclude one patient that discounted at day 36
due to an acute hepatitis E virus (HEV) super-infectionf Placebo
results are based on six subjects (two from each cohort).
ARB-1467 Phase 2 Trial
DesignThe Phase II trial is a multi-dose study in chronic
HBV patients who are also receiving stable nucleot(s)ide analog
therapy. The trial consists of four cohorts, the first three of
which enrolled eight subjects each (six receiving three monthly
doses of ARB-1467 and two receiving placebo) and the fourth is
enrolling twelve patients (all of whom will receive 5 bi-weekly
doses of ARB-1467). Cohorts 1, 2, and 4 include HBeAg- patients and
Cohort 3 included HBeAg+ patients. The protocol for Cohort 4 allows
for dosing to be extended to up to one year of ARB-1467 dosing for
patients who meet predefined response criteria.
Next Steps for ARB-1467In
addition to the ongoing Phase 2 Cohort 4, Arbutus will initiate a
new study in 2H17 to study longer term dosing of ARB-1467 in
combination with nucleot(s)ide analog therapy as well as pegylated
interferon or another immune modulator. This study will explore the
possibility of driving HBsAg to very low, if not undetectable,
levels with ARB-1467 along with an immune modulating mechanism.
While this study may include pegylated interferon as the immune
boosting component that could lead to later stage development,
Arbutus also plans to evaluate other immunomodulatory approaches,
such as its proprietary checkpoint inhibitor program, in future
combination studies. Arbutus’ core protein/capsid inhibitor AB-423,
which is being evaluated for monotherapy safety and activity in
2017, will be ready to be included in studies with RNAi and
approved agents in 2018. ARB-1740, a next generation RNAi agent, is
being evaluated in an ongoing multi-dosing study in HBV patients,
the results of which will be announced in 2H17 to enable a potency
comparison between ARB-1467 and ARB-1740.
About ARB-1467Arbutus’ RNAi
candidate ARB-1467 comprises three RNAi triggers that target all
four HBV transcripts, and has been shown in preclinical studies to
reduce all viral antigen levels as well as cccDNA and HBV DNA.
ARB-1467 utilizes Arbutus’ proprietary lipid nanoparticle
(LNP) platform, a clinically validated delivery technology which
has been tested in hundreds of patients.
About Arbutus
Arbutus Biopharma Corporation is a
biopharmaceutical company dedicated to discovering, developing and
commercializing a cure for patients suffering from chronic HBV
infection. Arbutus is headquartered in Vancouver, BC, and has
facilities in Warminster, PA. For more information, visit
www.arbutusbio.com.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”).
Forward-looking statements in this press release include statements
about announcing multi-dosing results of the fourth cohort of the
Phase II study of ARB-1467 in 3Q17; a the format of a new study of
ARB-1467 in 2H17 to evaluate longer dosing of ARB-1467 combined
with immunomodulatory agent, and potentially paving the way for
Phase IIb studies; including Arbutus’ core protein/capsid
inhibitor, AB-423, in studies with RNAi and approved agents in
2018; announcing the results of an ongoing multi-dosing study of
ARB-1740 in HBV patients in 2H17; continuing to advance the rest of
our pipeline to enable new treatment regimens for further
improvement in clinical outcomes; and developing a portfolio of HBV
assets to ultimately cure HBV through combination therapy.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of clinical trials, and the usefulness of the data; the
continued demand for Arbutus’ assets; and the stability of economic
and market conditions. While Arbutus considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies.
Additionally, there are known and unknown risk
factors which could cause Arbutus' actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated clinical trials may be more
costly or take longer to complete than anticipated, and may never
be initiated or completed, or may not generate results that warrant
future development of the tested drug candidate; Arbutus may not
receive the necessary regulatory approvals for the clinical
development of Arbutus' products; economic and market conditions
may worsen; and market shifts may require a change in strategic
focus.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus' Annual Report on
Form 10-K and Arbutus' continuous disclosure filings, which are
available at www.sedar.com and at www.sec.gov. All
forward-looking statements herein are qualified in their entirety
by this cautionary statement, and Arbutus disclaims any obligation
to revise or update any such forward-looking statements or to
publicly announce the result of any revisions to any of the
forward-looking statements contained herein to reflect future
results, events or developments, except as required by law.
Contact Information
Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com
Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com
Media
David Schull
Russo Partners
Phone: 858.717.2310
Email: david.schull@russopartnersllc.com
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