Preliminary Data Shows that Arbutus’ Capsid Inhibitor, AB-836 is Generally Safe and Well-Tolerated and Provides Robust Antiviral Activity
December 01 2021 - 11:58AM
Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company primarily focused on discovering,
developing and commercializing a broad portfolio of assets with
different modes of action to provide a cure for people with chronic
hepatitis B virus (cHBV) infection and to treat coronaviruses
(including COVID-19), today announced preliminary data from its
on-going Phase 1a/1b clinical trial demonstrating that its next
generation capsid inhibitor, AB-836, is generally safe and
well-tolerated in both healthy subjects and patients with cHBV and
provides robust antiviral activity.
Gaston Picchio, Ph.D., Chief Development Officer
at Arbutus, commented, “These preliminary results demonstrate that
AB-836 is generally safe and well-tolerated in both single- and
multiple-doses in healthy subjects and at doses up to 100mg
administered once daily for 28 days in cHBV patients. In addition,
the mean Day 28 drop in HBV DNA observed to date with a relatively
low dose suggests that AB-836 is a very potent inhibitor of HBV
replication making it an ideal candidate to potentially completely
suppress viral replication. We look forward to continuing to
evaluate the safety and efficacy of AB-836 in Part 3 of this
trial.”
The Phase 1a/1b clinical trial is designed to
evaluate the safety, tolerability, pharmacokinetics and antiviral
activity of single and multiple doses of AB-836 in healthy subjects
and patients with cHBV. The trial consists of three parts. Part 1
evaluated alternating single doses of AB-836 or placebo ranging
from 10mg to 175mg in a fasted or fed state in healthy subjects.
Part 2 evaluated multiple ascending doses of 50mg, 100mg or 150mg
of AB-836 or placebo once daily for 10 days in healthy volunteers.
Part 3, which is still on-going, is currently randomizing HBV DNA
positive cHBV patients who are HBeAg positive or negative to
receive either 50mg or 100mg of AB-836 or placebo once daily for 28
days.
In Parts 1 and 2, a total of 47 healthy subjects
were enrolled and dosed. There were no deaths or serious adverse
events (SAEs) observed. One healthy subject that received 50mg once
daily discontinued after treatment on day 13 due to an adverse
event (AE) of agitation. All but three AEs were mild (Grade 2
headache, agitation and bronchitis), and only one was assessed as
related to AB-836 (Grade 1 rash). There were no clinically
significant abnormalities in clinical laboratory tests, ECGs, vital
signs or physical exams noted.
In Part 3, 16 cHBV patients have been dosed thus
far with enrollment continuing. Among those who received 100mg once
daily for the full 28 days (n=4), robust antiviral activity was
observed at Day 28 of treatment with a mean (SE) log10 change from
baseline of -3.1 (0.5). There have been no deaths or AEs. One cHBV
patient that received 100mg of AB-836 had a transient increase in
ALT from baseline Grade 1 to Grade 3 at a single visit that
resolved with continued dosing and had no associated symptoms.
There were no clinically significant abnormalities in ECGs, vital
signs or physical exams noted.
Arbutus is continuing to enroll and dose cHBV
patients in Part 3 of the clinical trial and anticipates
presenting additional data at a medical conference in 2022.
About AB-836
AB-836 is a next generation oral hepatitis B
virus (HBV) capsid inhibitor that interacts with HBV core protein,
which in turn is required for viral replication. The current
standard-of-care therapy for HBV is primarily nucleos(t)ide
analogues that inhibit the viral polymerase and significantly
reduce, but do not eliminate viral replication. AB-836 in
combination with nucleos(t)ide analogues is designed to completely
eliminate viral replication in infected cells by preventing the
assembly of functional viral capsids. In addition, AB-836 has been
shown to inhibit the replenishment of covalently closed circular
DNA (cccDNA), the viral genetic reservoir which the virus needs to
replicate itself.
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 250 million people worldwide suffer from
chronic HBV infection, while other estimates indicate that
approximately 2 million people in the United States suffer from
chronic HBV infection. Approximately 900,000 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 primarily focused on
discovering, developing and commercializing a broad portfolio of
assets with different modes of action to provide a cure for people
with chronic hepatitis B virus (HBV) infection. The Company is
advancing multiple product candidates with distinct mechanisms of
action that suppress viral replication, reduce surface antigen and
reawaken the immune system. Arbutus believes this three-prong
approach is key to transforming the treatment and developing a
potential cure for chronic HBV infection. Arbutus’ HBV product
pipeline includes RNA interference (RNAi) therapeutics, oral capsid
inhibitors, oral compounds that inhibit PD-L1 and oral HBV RNA
destabilizers. In addition, Arbutus has an ongoing drug discovery
and development program directed to identifying orally active
agents for treating coronaviruses (including COVID-19). 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 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.
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, 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; 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. CollierPresident and CEOPhone:
267-469-0914Email: ir@arbutusbio.com
Lisa M. CaperelliVice President, Investor RelationsPhone:
215-206-1822Email: lcaperelli@arbutusbio.com
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