Arbutus receives regulatory clearance to initiate Phase 1a/1b Clinical Trial of AB-729
June 20 2019 - 7:30AM
Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading
Hepatitis B Virus (HBV) therapeutic solutions company, today
announced it has received regulatory clearance to initiate a Phase
1a/1b clinical trial of AB-729, Arbutus’
subcutaneously-administered RNA interference (RNAi) agent. AB-729
employs a single RNAi trigger that has been shown in preclinical
models to span all HBV transcripts, reduce all viral antigens,
including hepatitis B surface antigen (HBsAg) expression, and
inhibit HBV replication. This RNAi agent uses Arbutus’ proprietary
covalently conjugated N-acetylgalactosamine (GalNAc) hepatocyte
targeting technology which is expected to allow for once-a-month
dosing. As previously announced on May 3rd, a regulatory
authority requested that Arbutus complete its ongoing 3- and
6-month toxicology studies before commencing the single ascending
portion of the Phase 1a/1b clinical trial of AB-729. Based on
further interaction with the regulatory authority, a revised
protocol was submitted and Arbutus has received clearance to begin
the Phase 1a/1b clinical trial.
Dr. Gaston Picchio, Arbutus’s Chief Development
Officer, said, “The Phase 1a/1b clinical trial of AB-729 is
expected to initiate shortly and will initially be evaluated in
healthy volunteers followed by chronic hepatitis B patients in
single ascending dose cohorts.”
Dr. Picchio, added, “We believe the combination
of AB-729 and AB-506, our oral capsid inhibitor, has the potential
to result in more profound inhibition of HBV replication in
conjunction with a reduction in HBsAg levels thus enabling a
reawakening of the patient’s immune system. We also believe that
these combined effects should lead to significantly higher rates of
sustained HBsAg loss than the current standard of care after a
yet-to-be-established finite dosing period.”
About the AB-729 Phase 1a/1b Clinical
TrialAB-729-001 is a single and multiple dose clinical
trial to investigate the safety, tolerability, pharmacokinetics,
and pharmacodynamics of AB-729 administered by subcutaneous
injection to healthy subjects and patients with chronic hepatitis B
infection.
About AB-729AB-729 is a RNA
interference (RNAi) therapeutic targeted to hepatocytes using
Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc)
delivery technology that enables subcutaneous delivery and we
expect monthly dosing. AB-729 inhibits viral replication and
reduces all HBV antigens, including hepatitis B surface antigen
(HBsAg) in preclinical models. Reducing HBsAg is thought to be a
key prerequisite to enable reawakening of a patient’s immune system
to respond to the virus.
About AB-506AB-506 is an oral
HBV capsid inhibitor. HBV core protein assembles into a capsid
structure, which is required for viral replication. The current
standard-of-care therapy for HBV, primarily nucleoside analogues
that work by stopping the viral polymerase, significantly reduce
virus replication, but not completely. Capsid inhibitors inhibit
replication by preventing the assembly of functional viral capsids
and also by inhibiting the uncoating step of the viral life cycle
thus reducing the formation of new covalently closed circular DNA
("cccDNA"), the viral reservoir which resides in the cell
nucleus.
About Arbutus Arbutus Biopharma
Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical
company dedicated to discovering, developing and commercializing a
cure for patients suffering from chronic Hepatitis B infection.
Arbutus is developing multiple drug candidates, each of which have
the potential to improve upon the standard of care and contribute
to a curative combination regimen. 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 expectation for once-a-month dosing; our expectation to
initiate the Phase 1a/1b clinical trial of AB-729 shortly and the
clinical trial design for such clinical trial; our belief that the
combination of AB-729 and AB-506 has the potential to result in
more profound inhibition of HBV replication in conjunction with a
reduction in HBsAg levels thus enabling a reawakening of the
patient’s immune system; our belief that the combined effects of
AB-729 and AB-506 should lead to significantly higher rates
of sustained HBsAg loss than the current standard of care after a
yet-to-be-established finite dosing period; and the potential for
our drug candidates to improve upon the standard of care and
contribute to a curative combination regimen.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the timely receipt of
expected payments; the effectiveness and timeliness of preclinical
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.
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 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 Quarterly Reports on Form 10-Q 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
InvestorsMark J. MurrayPresident and CEOPhone:
604-419-3200Email: ir@arbutusbio.com
MediaPam Murphy Investor Relations Consultant
Phone: 604-419-3200 Email: ir@arbutusbio.com
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