Arbutus Announces Decision to Discontinue AB-452 and to Pursue Development of a Next Generation HBV Specific Oral RNA-Destabi...
11 February 2020 - 12:00AM
Arbutus Biopharma Corporation (Nasdaq: ABUS), announced today
its decision to discontinue AB-452, its first generation orally
available hepatitis B (HBV) specific RNA-destabilizer, and to
continue research and development of a next generation oral HBV
RNA-destabilizer. In October 2018, Arbutus announced its decision
to delay the initiation of a planned 28-day Phase 1a/1b clinical
trial for AB-452 in order to further evaluate the safety of the
compound. This decision was based on findings in 90-day preclinical
safety studies in two species. Since that time Arbutus has
extensively reviewed and further characterized these preclinical
findings, including repeating the 90-day safety studies.
Michael J. Sofia, Ph.D., Chief Scientific
Officer of Arbutus, added, “After reviewing all the data from the
preclinical studies, and in consultation with external regulatory
and pre-clinical experts, we have decided to not move AB-452
forward. We continue to believe, however, that the HBV RNA
destabilizer mechanism of action is very compelling and has the
potential to lead to an oral therapy. We intend to vigorously
pursue next generation compounds in this area.”
Arbutus also reiterated its earlier guidance for
both AB-729 and AB-836. AB-729 is a subcutaneously delivered RNAi
agent which has been shown in preclinical models to reduce viral
antigens, including hepatitis B surface antigen (HBsAg) expression,
and to inhibit HBV replication. In July 2019, the Company
initiated a single and multiple dose Phase 1a/1b clinical trial for
AB-729, designed to investigate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of AB-729 in healthy
volunteers and in subjects with chronic hepatitis B (CHB)
infection. Preliminary safety data in single-dose cohorts of
healthy subjects and safety and efficacy data in single-dose
cohorts of subjects with CHB infection are expected late this
quarter. For AB-836, Arbutus’ next generation capsid inhibitor, the
Company expects to complete investigational new drug enabling
studies by the end of the year.
The Company believes that this compound has the
potential for increased efficacy and an enhanced resistance profile
relative to its previous generation capsid inhibitor, AB-506.
William H. Collier, President and Chief
Executive Officer of Arbutus, stated, “Arbutus remains committed to
developing a range of medicines with differing mechanisms of action
that can be used in combination for treatment of chronic HBV
infection. The Company is on track to deliver on its key pipeline
objectives for 2020; we look forward to announcing our preliminary
safety and efficacy data for AB-729 later this quarter and to
completing IND enabling studies for AB-836 by the end of the
year.”
About Oral
RNA-Destabilizers
Small molecule HBV RNA destabilizers are orally
active agents that cause the destabilization and ultimate
degradation of HBV RNAs. These agents result in the reduction of
HBsAg, HBeAg, pgRNA, and core protein in both whole cell systems
and animal models. They have the potential to selectively impact
HBV versus other RNA or DNA viruses and demonstrate pangenotypic
characteristics. HBV RNA destabilizers have demonstrated additive
effects in combination with other mechanism of action anti-HBV
agents.
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. 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-836
AB-836 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 inhibiting the viral
polymerase, significantly reduce virus replication, but not
completely. Capsid inhibitors inhibit replication by preventing the
assembly of functional viral capsids. They also have been shown to
inhibit 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 (HBV) 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 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 expectations regarding the timing and clinical
development of our product candidates; our expectation to announce
AB-729 preliminary Phase 1a/1b data late in the first quarter of
2020; our belief that the HBV RNA destabilizer mechanism of action
is very compelling and has the potential to lead to an oral
therapy; our intention to vigorously pursue additional next
generation compounds; our guidance for AB-729 and AB-836, including
our expectation to complete investigational new drug enabling
studies by the end of the year; our belief that AB-836 has the
potential for increased efficacy and an enhanced resistance profile
relative to AB-506; and our belief that we are on track to deliver
on our key pipeline objectives for 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 and MediaWilliam 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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