Arbutus Presents Preliminary AB-729 and Pegylated Interferon Alfa-2a Combination Data at the EASL Congress 2023
21 Giugno 2023 - 8:01AM
Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the
“Company”), a clinical-stage biopharmaceutical company leveraging
its extensive virology expertise to develop novel therapeutics that
target specific viral diseases, today announced that preliminary
data from its on-going Phase 2a clinical trial evaluating the
safety, tolerability and antiviral activity of the combination of
AB-729, the Company’s lead RNAi therapeutic, and pegylated
interferon alfa-2a (IFN) in patients with chronic hepatitis B virus
(cHBV) was presented today at the European Association for the
Study of the Liver (EASL) Congress. The preliminary data suggests
that the addition of IFN to AB-729 treatment was generally well
tolerated and appears to result in continued HBsAg declines in some
patients.
William Collier, President and Chief Executive
Officer of Arbutus, commented, “These data continue to support our
strategy of utilizing AB-729 as a cornerstone in a combination
therapeutic for patients with cHBV. In this trial, some patients
that received 12 weeks or more of IFN after AB-729 treatment saw
promising declines in surface antigen, which continues to reinforce
our confidence in AB-729’s ability to effectively suppress HBsAg.
While this is a small sample size and additional follow-up is
needed, we believe that the combination of AB-729 and IFN is both
safe and lowers surface antigen, which in turn, may allow the
patient’s immune system to control the virus. We look forward to
providing more data as patients continue to receive treatment.”
Forty-three virally suppressed, HBeAg negative
cHBV patients were enrolled in the clinical trial and received a
lead-in of AB-729 (60mg every 8 weeks) plus nucleos(t)ide analog
(NA) therapy for 24 weeks followed by 12 or 24 weeks of IFN with or
without additional AB-729 doses. The preliminary data showed the
following:
- The mean HBsAg decline from
baseline during the lead-in phase was 1.6 log10 at week 24 of
treatment which is comparable to what was previously seen in other
clinical trials with AB-729.
- HBsAg levels <100 IU/mL were
noted during the treatment period in 93% (38 of 41 randomized) of
the patients.
- Four patients have reached HBsAg
below the lower limit of quantitation (LLOQ) during IFN treatment,
however, none of the patients have achieved sustained seroclearance
to date.
- AB-729 treatment alone or in
combination with IFN was generally well tolerated. There were no
serious adverse events (SAEs), discontinuations or AB-729 treatment
discontinuations. IFN-related treatment emergent adverse events
(TEAEs) were consistent with the known safety profile. Five
patients required IFN dose modifications due to laboratory
abnormalities.
The clinical trial remains ongoing with most
patients still in the early IFN treatment period continuing to be
followed for on-treatment responses. After completion of the IFN
treatment period, patients are followed for an additional 24 weeks
on NA therapy alone, then assessed for NA discontinuation. Three
patients have been evaluated to stop NA treatment to date, with one
meeting the protocol-defined criteria to stop NA treatment.
The posters that were presented at EASL 2023 can
be accessed through the Investors section of Arbutus’ website under
Publications at https://www.arbutusbio.com/publications/.
About AB-729
AB-729 is an RNA interference (RNAi) therapeutic
specifically designed to reduce all HBV viral proteins and
antigens, including hepatitis B surface antigen, which is thought
to be a key prerequisite to enable reawakening of a patient’s
immune system to respond to the virus. AB-729 targets hepatocytes
using Arbutus’ novel covalently conjugated N-Acetylgalactosamine
(GalNAc) delivery technology that enables subcutaneous delivery.
Clinical data generated thus far has shown single- and multi-doses
of AB-729 to be generally safe and well-tolerated while providing
meaningful reductions in hepatitis B surface antigen and hepatitis
B DNA. AB-729 is currently in multiple Phase 2a clinical
trials.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by the hepatitis B virus (HBV). HBV can
cause chronic infection which leads to a higher risk of death from
cirrhosis and liver cancer. Chronic HBV infection represents a
significant unmet medical need. The World Health Organization
estimates that over 290 million people worldwide suffer from
chronic HBV infection, while other estimates indicate that
approximately 2.4 million people in the United States suffer from
chronic HBV infection. Approximately 820,000 people die every year
from complications related to chronic HBV infection despite the
availability of effective vaccines and current treatment
options.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is
a clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to develop novel therapeutics that target
specific viral diseases. Our current focus areas include Hepatitis
B virus (HBV), SARS-CoV-2, and other coronaviruses. To address HBV,
we are developing a RNAi therapeutic, an oral PD-L1 inhibitor, and
an oral RNA destabilizer to potentially identify a combination
regimen with the aim of providing a functional cure for patients
with chronic HBV by suppressing viral replication, reducing surface
antigen and reawakening the immune system. We believe our lead
compound, AB-729, is the only RNAi therapeutic with evidence of
immune re-awakening. AB-729 is currently being evaluated in
multiple phase 2 clinical trials. We also have an ongoing drug
discovery and development program directed to identifying novel,
orally active agents for treating coronaviruses, (including
SARS-CoV-2), for which we have nominated a compound and have begun
IND-enabling pre-clinical studies. In addition, we are also
exploring oncology applications for our internal PD-L1 portfolio.
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 our future development plans for our product candidates; the
expected cost, timing and results of our clinical development plans
and clinical trials with respect to our product candidates; our
expectations with respect to the release of data from our clinical
trials and the expected timing thereof; our expectations and goals
for our collaborations with third parties and any potential
benefits related thereto; and the potential for our product
candidates to achieve success in clinical trials.
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 preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; 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, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic and patent
litigation matters.
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 pre-clinical studies and
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
product candidate; Arbutus may elect to change its strategy
regarding its product candidates and clinical development
activities; Arbutus may not receive the necessary regulatory
approvals for the clinical development of Arbutus’ products;
economic and market conditions may worsen; uncertainties associated
with litigation generally and patent litigation specifically;
Arbutus and its collaborators may never realize the expected
benefits of the collaborations; market shifts may require a change
in strategic focus; and the ongoing COVID-19 pandemic could
significantly disrupt Arbutus’ clinical development programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic 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 and Media
Lisa CaperelliVice President, Investor Relations Phone:
215-206-1822Email: lcaperelli@arbutusbio.com
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