Arbutus Receives Regulatory Approval to Initiate a Phase 1a/1b Clinical Trial with AB-836, an Oral Capsid Inhibitor for the T...
March 16 2021 - 7:30AM
Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company primarily focused on developing a cure
for people with chronic hepatitis B virus (HBV) infection, as well
as therapies to treat coronaviruses (including COVID-19), today
announced that it has received regulatory approval to initiate a
Phase 1a/1b clinical trial with AB-836, its proprietary oral capsid
inhibitor for the treatment of HBV infection.
“We are pleased that we have received regulatory approval to
proceed with our Phase 1a/1b clinical trial for AB-836, and we
expect to begin dosing shortly. Initiation of this trial is an
important step towards potential future proprietary combinations
with AB-729 and other mechanisms,” said William Collier, President
and Chief Executive Officer of Arbutus.
Dr. Michael Sofia, Chief Scientific Officer of Arbutus, added,
“Based on pre-clinical studies with AB-836, which is derived from a
novel chemical series in this class, we believe it has the
potential for improved clinical efficacy and safety as well as a
favorable resistance profile relative to earlier generation capsid
inhibitors. In addition, we believe that the strong potency of
AB-836 as shown in in vitro testing should allow active engagement
of the second mechanism of inhibiting cccDNA replenishment at
clinically relevant doses.”
About AB-836
AB-836 is an oral capsid inhibitor for the
treatment of chronic hepatitis B infection. It is from a novel
chemical series that is differentiated from competitor compounds
and has the potential for increased efficacy and an enhanced
resistance profile. AB-836 binds to a novel site within the core
protein dimer-dimer interface and has shown in in vitro testing to
be active against nucleotide analog resistant variants and also has
the potential to address certain known capsid resistant variants.
AB-836 has been shown in in vitro studies to be active against
nucleoside resistant variants and therapeutically relevant activity
against key core protein resistant variants I105T and T33N. AB-836
is anticipated to be combinable with other drugs having different
mechanisms of action for treating HBV, including AB-729, and is
also anticipated to be dosed once daily.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by 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 is a publicly
traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated
to discovering, developing and commercializing a cure for people
with chronic hepatitis B virus (HBV) infection. The Company is
advancing multiple drug product candidates that may be combined
into a potentially curative regimen for chronic HBV infection.
Arbutus has also initiated a drug discovery and development effort
for treating coronaviruses (including COVID-19). For more
information, please 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 the Company’s expectation to begin dosing in a Phase 1a/1b
clinical trial for AB-836 shortly; the Company’s belief that AB-836
has the potential for improved clinical efficacy and safety as well
as a favorable resistance profile relative to earlier generation
capsid inhibitors; the Company’s belief regarding the strong
potency of AB-836 and its ability to allow active engagement of the
second mechanism of inhibiting cccDNA replenishment at clinically
relevant doses; AB-836’s potential to address certain known capsid
resistant variants; and the Company’s anticipation for AB-836 to be
combinable with other drugs having different mechanisms of action
for treating HBV and to be dosed once daily.
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, and may never be initiated or completed, or may not
generate results that warrant future development of the tested drug
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; 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 InformationInvestors and
MediaWilliam H. CollierPresident and CEOPhone:
267-469-0914Email: ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone: 267-469-0914Email:
ir@arbutusbio.com
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