Assembly Biosciences, Inc. (Nasdaq: ASMB) and Arbutus Biopharma
Corporation (Nasdaq: ABUS), today announced that the companies have
entered into a clinical collaboration agreement to evaluate
Assembly’s lead hepatitis B virus (HBV) core inhibitor candidate
ABI-H0731 in combination with Arbutus’ proprietary GalNAc delivered
RNAi therapeutic AB-729 and standard-of-care nucleos(t)ide reverse
transcriptase inhibitor (NrtI) therapy for the treatment of
patients with chronic HBV infection.
A randomized, multi-center, open-label Phase 2 clinical trial
will explore the safety, pharmacokinetics, and antiviral activity
of the triple combination of HBV core inhibitor ABI-H0731, RNAi
therapeutic AB-729 and an NrtI compared to the double combinations
of ABI-H0731 with an NrtI and AB-729 with an NrtI. This clinical
trial is projected to initiate in the first half of 2021 and enroll
approximately 60 virologically-suppressed patients with HBeAg
negative or positive chronic HBV infection. Patients will be dosed
for 48 weeks, with a 24 week follow-up period. As part of the
collaboration, the companies may add cohorts in the future, to
evaluate other patient populations and/or combinations.
“Our team at Assembly is committed to driving the field of HBV
research toward the ultimate goals of finite therapy and cure,”
said John McHutchison, AO, MD, Chief Executive Officer and
President of Assembly Biosciences. “One of our key priorities for
this year has been to execute a clinical collaboration to initiate
a new combination therapy trial, as we believe that multi-drug
combinations with non-overlapping mechanisms may result in higher
response rates and potentially shorten the duration of treatment.
We are excited to combine what we view as the most advanced core
inhibitor with a promising RNAi therapeutic in this new trial as we
continue to work to advance novel treatment options for patients
living with this chronic disease.”
William Collier, President and Chief Executive Officer of
Arbutus, stated, “Arbutus is focused on discovering and developing
a cure for chronic hepatitis B. We maintain this can best be
accomplished through a combination of agents with different
mechanisms of action that target distinct parts of the virus
lifecycle. To this end, we are advancing a proprietary portfolio of
compounds at various stages of clinical and preclinical development
that have the potential to lead to a functional cure with a finite
treatment duration.”
Mr. Collier added, “This clinical collaboration in which both
companies share expertise and costs has the potential to provide
proof of concept data regarding the safety and efficacy of
combining some of the most promising drug candidates and expedite
efforts to advance a much needed HBV treatment regimen.”
About ABI-H0731, Assembly’s Lead HBV Core
InhibitorAssembly’s HBV portfolio includes three
clinical-stage small molecule candidates, all of which are HBV core
inhibitors that target multiple steps of the HBV lifecycle. In
Phase 2 clinical trials, first-generation core inhibitor ABI-H0731
administered with nucleos(t)ide analogue reverse transcriptase
inhibitor (NrtI) therapy has been well-tolerated, has shown
statistically superior antiviral activity in HBV DNA suppression
compared to NrtI therapy alone, and has demonstrated significant
declines in HBV pgRNA that may indicate decreased cccDNA levels. In
the ongoing Phase 2 open-label extension trial, Assembly has begun
transitioning patients off combination therapy, to then monitor for
sustained virologic response (SVR).
About Arbutus’ AB-729 (Gal-Nac-RNAi)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 in preclinical models. Reducing
hepatitis B surface antigen is thought to be a key prerequisite to
enable reawakening of a patient’s immune system to respond to the
virus. In an ongoing single- and multi-dose Phase 1a/1b
clinical trial, AB-729 demonstrated positive preliminary
safety and tolerability data and meaningful reductions in hepatitis
B surface antigen.
About HBVChronic hepatitis B virus (HBV)
infection is a debilitating disease of the liver that afflicts over
250 million people worldwide with up to 90 million people in China,
as estimated by the World Health Organization. HBV is a global
epidemic that affects more people than hepatitis C virus (HCV) and
HIV infection combined—with a higher morbidity and mortality rate.
HBV is a leading cause of chronic liver disease and need for liver
transplantation, and up to one million people worldwide die every
year from HBV-related causes.
The current standard of care for patients with chronic HBV
infection is life-long suppressive treatment with medications that
reduce, but do not eliminate, the virus, resulting in very low cure
rates. There is a significant unmet need for new therapies to treat
HBV.
About Assembly Biosciences Assembly
Biosciences, Inc. is a clinical-stage biotechnology company
developing innovative therapeutics targeting hepatitis B virus
(HBV) and diseases associated with the microbiome. The HBV program
is focused on advancing a new class of potent, oral core inhibitors
that have the potential to increase cure rates for chronically
infected patients. The microbiome program is developing novel
oral live microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain
identification and selection, GMP manufacturing expertise and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information,
visit assemblybio.com.
About ArbutusArbutus Biopharma
Corporation is a publicly traded (Nasdaq: ABUS)
biopharmaceutical company 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.
Assembly’s Forward-Looking Statements The
information in this press release contains forward-looking
statements that are subject to certain risks and uncertainties that
could cause actual results to materially differ from those
projected or implied. These risks and uncertainties include:
Assembly and Arbutus’ ability to initiate and complete clinical
trials for ABI-H0731, AB-729, and NrtI in the currently anticipated
timeframes; whether the contemplated clinical trials meet their
primary endpoint(s); safety and efficacy data from clinical trials
may not warrant further development of ABI-H0731 or the combination
of ABI-H0731 with AB-729 and NrtI; clinical data with respect to
the ABI-H0731, AB-729 and NrtI combination, may not be
differentiated from other companies’ clinical data; Assembly may
not observe sustained virologic response (SVR) in patients who are
treated with its core inhibitors; any impact that the spread of the
coronavirus and resulting COVID-19 pandemic may have on initiation
and continuation of the clinical trials under the collaboration;
and other risks identified from time to time in Assembly’s reports
filed with the U.S. Securities and Exchange Commission (the SEC).
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. Readers
are cautioned not to rely on these forward-looking statements.
Assembly intends such forward-looking statements to be covered by
the safe harbor provisions contained in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. More information about
the risks and uncertainties faced by Assembly are more fully
detailed under the heading “Risk Factors” in Assembly’s filings
with the Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K. Except as required by law,
Assembly assumes no obligation to update publicly any
forward-looking statements, whether resulting from new information,
future events or otherwise.
Arbutus’ Forward-Looking Statements 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 Assembly and Arbutus’ ability to
initiate and complete clinical trials for AB-729, ABI-H0731 and an
NrtI in the currently anticipated timeframes; expectations
regarding the timing and number of patients enrolled in the Phase 2
clinical trial; the expected dosing of the Phase 2 clinical trial;
the possibility of including additional cohorts under the
collaboration agreement; the potential for multi-drug combinations
with non-overlapping mechanisms to result in higher response rates
and shorten the duration of treatment; and expectations regarding
the safety and efficacy of Arbutus’ and Assembly’s product
candidates.
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 clinical trials for AB-729,
ABI-H0731 and an NrtI, and the usefulness of the data; the
continued demand for Arbutus’ and Assembly’s 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 clinical trials for AB-729, ABI-H0731 and an
NrtI 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 AB-729,
ABI-H0731, and an NrtI; changes in Arbutus’ or Assembly’s strategy
regarding its product candidates and clinical development
activities; economic and market conditions may worsen; market
shifts may require a change in strategic focus; and the ongoing
COVID-19 pandemic could significantly disrupt our 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.
Assembly ContactsInvestors and Media:Lauren
GlaserSenior Vice President, Investor Relations and Corporate
Affairs(415) 521-3828lglaser@assemblybio.com
Arbutus Contacts Investors and Media:William H.
CollierPresident and CEOPhone: 604-419-3200ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone:
604-419-3200ir@arbutusbio.com
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