Arbutus Announces Decision to Discontinue Development of AB-506, an Oral Capsid Inhibitor for the Treatment of Chronic Hepat...
October 03 2019 - 4:05PM
Arbutus Biopharma Corporation (Nasdaq: ABUS), a Hepatitis B
Virus (HBV) therapeutic solutions company, today announced its
decision to discontinue the clinical development of AB-506, an oral
capsid inhibitor. AB-506 was in a Phase 1a/1b clinical trial for
the treatment of chronic hepatitis B (CHB).
William H. Collier, President and Chief
Executive Officer of Arbutus, stated, “We have observed two cases
of acute hepatitis in our Phase 1a 28-day clinical trial in healthy
volunteers. Consequently, the clinical trial and further
development of AB-506 have been stopped.”“The two subjects are
experiencing resolution of their acute hepatitis. We will continue
to follow them and the other study participants, as safety is our
highest priority at Arbutus,” said Gaston Picchio, Ph.D. Chief
Development Officer of Arbutus. “We intend to present results from
the AB-506 Phase 1a/1b clinical trial along with further details
regarding the two cases of acute hepatitis at an appropriate
scientific meeting later in 2019.”Michael J. Sofia, Ph.D., Chief
Scientific Officer of Arbutus, added, “While we are disappointed in
these recent clinical findings, we have a number of oral follow-on
capsid inhibitor compounds with distinct chemical scaffolds that we
believe have the potential to contribute to the inhibition of HBV
replication as part of a combination regimen. Our objective is to
select one of several lead compounds for IND-enabling studies by
December of this year.”As a result of the decision to discontinue
further development of AB-506, Arbutus no longer expects to
initiate a combination study of AB-506 and AB-729 in the second
half of 2020.About AB-506
AB-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
AB-729
AB-729 is a RNA interference (RNAi) therapeutic
targeted to hepatocytes using Arbutus’ novel covalently conjugated
N-acetylgalactosamine (GalNAc) delivery technology that enables
subcutaneous delivery with expected 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
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 ability to deliver a cure for people with chronic HBV;
our expectations regarding the timing and clinical development of
our product candidates; our intention to present results from the
AB-506 Phase 1a/1b clinical trial along with further details
regarding the two cases of acute hepatitis at an appropriate
scientific meeting; our confidence that capsid inhibition is
important to achieve a potential cure for CHB; our belief that our
oral follow on capsid inhibitor compounds have the potential to
contribute to the inhibition of HBV replication as part of a
combination regimen; our objective to select one of several lead
capsid inhibitor compounds for IND-enabling studies by December of
this year; and our expectation that we will no longer initiate a
combination study of AB-506 and AB-729 in the second half of
2020.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 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: delays in the selection of and the
advancement of an additional capsid inhibitor compound into lead
optimization, 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, 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 William H. Collier President and CEO
Phone: 604-419-3200 Email: ir@arbutusbio.com
Pam Murphy Investor Relations Consultant Phone: 604-419-3200
Email: ir@arbutusbio.com
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