Arbutus Completes Enrollment in its Phase 2a Clinical Trial Combining AB-729 with NA Therapy and Peginterferon alfa-2a in Patients with Chronic Hepatitis B Virus Infection
13 December 2022 - 11:30PM
Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company leveraging its extensive virology
expertise to develop novel therapeutics that target specific viral
diseases, today announced preliminary data from the AB-729 lead-in
portion of its Phase 2a clinical trial combining AB-729 with
nucleos(t)ide analogue (NA) therapy and Peginterferon
alfa-2a (IFN). The data reinforces AB-729’s surface antigen
reducing-capacity, while continuing to exhibit a generally safe and
well-tolerated profile in patients with chronic Hepatitis B virus
(cHBV). Given that only a few patients are in the early weeks of
the IFN phase of the clinical trial, the Company intends to provide
additional updated data in the first half of next year which will
include preliminary results of the IFN portion of the trial.
Enrollment is complete in the clinical trial
with 43 patients having received at least one dose of AB-729. For
the first 15 patients who reached week 16 of treatment and received
two doses of AB-729 plus NA therapy, the mean (SE) HBsAg decline
was 1.51 log (0.12), comparable to the decline observed at the same
timepoint in the completed Phase 1b clinical trial AB-729-001 (1.56
log (0.1)). As the trial progresses, patients will be randomized
into various treatment arms which include the combination of
AB-729, NA therapy and short courses of IFN for either 12 or 24
weeks.
Gaston Picchio, Ph.D., Chief Development Officer
at Arbutus, commented, “These preliminary Phase 2a data are
reassuring since they confirm previous Phase 1b results showing
that AB-729 is capable of consistently reducing HBsAg while
maintaining a safe and well-tolerated profile. We look forward to
seeing the effects of different courses of IFN in combination with
AB-729 to reduce HBsAg throughout 2023.”
The randomized, open label, multicenter Phase 2a
proof-of-concept clinical trial is designed to investigate the
safety and antiviral activity of AB-729 in combination with ongoing
NA therapy and short courses of IFN. The trial enrolled
NA-suppressed, HBeAg negative, non-cirrhotic patients with cHBV.
Patients are predominantly of Asian descent. The mean baseline
HBsAg was 3.0 logs. All patients receive 60 mg of AB-729 every 8
weeks for 24 weeks after which they are randomized into one of four
arms to receive NA therapy plus IFN for 12 or 24 weeks with or
without additional doses of AB-729.
After completion of the assigned IFN treatment
period, all patients will remain on NA therapy for an additional
24-weeks and will then discontinue NA treatment provided they meet
pre-defined stopping criteria. Patients who stop NA therapy will
enter an intensive follow-up period of 48 weeks.
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
enabling subcutaneous delivery. Clinical data generated thus far
has shown single- and multi-doses of AB-729 to be generally safe
and well-tolerated, while also 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. It 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 coronavirus (including SARS-CoV-2). In
addition, we are exploring oncology applications for our internal
PD-L1 portfolio. For more information, visit
www.arbutusbio.com.
Forward-Looking Statements and
InformationThis 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 William H. Collier President and CEO Phone:
267-469-0914 Email: ir@arbutusbio.comLisa M.
Caperelli Vice President, Investor Relations Phone:
215-206-1822 Email: lcaperelli@arbutusbio.com
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Apr 2023 to Apr 2024