Assembly Biosciences, Inc. (Nasdaq: ASMB) and Arbutus Biopharma
Corporation (Nasdaq: ABUS) today announced the initiation of a
Phase 2 clinical trial of Assembly Bio’s investigational hepatitis
B virus (HBV) core inhibitor candidate, also known as a capsid
inhibitor, vebicorvir (VBR), in combination with Arbutus’
proprietary GalNAc delivered RNAi therapeutic candidate, AB-729,
and standard-of-care nucleos(t)ide reverse transcriptase inhibitor
(NrtI) therapy for the treatment of patients with chronic HBV
infection. The companies announced a clinical collaboration
agreement in August 2020.
The randomized, multi-center, open-label Phase 2 clinical trial
will evaluate the safety, pharmacokinetics, and antiviral activity
of the triple combination of VBR, AB-729 and an NrtI compared to
the double combinations of VBR with an NrtI and AB-729 with an
NrtI. Approximately 60 virologically-suppressed patients with HBeAg
negative chronic HBV are expected to be enrolled across these three
treatment arms. Patients will be dosed for 48 weeks with VBR 300 mg
orally once daily and AB-729 60 mg subcutaneously every 8 weeks,
with a 48-week follow-up period. The primary objective of the trial
is to evaluate the safety and tolerability of the triple
combination, while secondary objectives of the trial include
evaluating the effect of the triple combination in reducing HBV
viral biomarkers such as HBV DNA, HBV pgRNA and HBsAg. Additional
cohorts may be added in the future to evaluate other patient
populations and/or combinations.
“We are excited to move forward with our collaborators in this
proof-of-concept Phase 2 clinical trial designed to evaluate
multiple complementary mechanisms of action. Importantly, this
trial supports our long-standing belief that multi-drug
combinations will be needed to provide patients with chronic
hepatitis B a much needed and durable functional cure,” stated
Gaston Picchio, PhD, Chief Development Officer at Arbutus. “We
believe reducing HBsAg will be a key component of future HBV
curative therapies. AB-729, Arbutus’ lead HBV asset, has
demonstrated competitive HBsAg reductions and a favorable safety
and tolerability profile in an ongoing Phase 1b clinical trial, and
we are gratified to have it progress in this combination
trial.”
"Our lead core inhibitor candidate, vebicorvir, in combination
with standard-of-care NrtI therapy, demonstrates enhanced antiviral
activity with a favorable safety profile fueling our belief that
core inhibitors will become a central component of finite and
curative therapies for patients with HBV,” said Luisa Stamm,
MD, PhD, Chief Medical Officer at Assembly Bio. “We also believe
that exploring multi-drug combinations with complementary
mechanisms of action could increase response rates. We look forward
to exploring the promise of combination therapies in our work with
Arbutus.”
About Vebicorvir, Assembly’s Lead HBV Core
InhibitorAssembly Bio’s HBV portfolio includes three
clinical-stage small molecule candidates, all of which are HBV core
inhibitors that target multiple steps of the HBV replication cycle.
In Phase 2 clinical trials, first-generation core inhibitor
vebicorvir (VBR) administered with nucleos(t)ide analogue reverse
transcriptase inhibitor (NrtI) therapy demonstrated a favorable
safety profile and led to greater viral suppression of both HBV DNA
and HBV pgRNA than NrtI therapy alone. VBR is advancing in multiple
Phase 2 combination studies.
About Arbutus’ AB-729 AB-729 is an 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. Based upon clinical data generated thus far in an ongoing
single- and multi-dose Phase 1a/1b clinical trial, AB-729 has
demonstrated positive 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
approximately 270 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 BiosciencesAssembly Bio is a
clinical-stage biotechnology company committed to bringing finite
and curative therapies to the 270 million people living with
hepatitis B virus (HBV) worldwide. A pioneer in the development of
a new class of potent, oral core inhibitor drug candidates,
Assembly Bio’s approach aims to break the complex viral replication
cycle of HBV to free patients from a lifetime of therapy. Assembly
Bio’s strategy toward cure includes a leading portfolio of more
potent, next-generation core inhibitors, proof-of-concept
combination studies and a research program focused on the discovery
of novel HBV targets. For more information,
visit assemblybio.com.
About ArbutusArbutus 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, visit www.arbutusbio.com.
Assembly Bio’s Forward-Looking StatementsThe
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. These
risks and uncertainties include: Assembly Bio’s ability to
initiate and complete clinical trials involving its HBV
therapeutic product candidates, including trials contemplated by
Assembly Bio’s clinical collaboration agreements, in the
currently anticipated timeframes; safety and efficacy data from
clinical studies may not warrant further development of
Assembly Bio’s product candidates; clinical and nonclinical data
presented at conferences may not differentiate Assembly Bio’s
product candidates from other companies’ candidates; continued
development and commercialization of Assembly Bio’s HBV
product candidates, if successful, in the China territory will be
dependent on, and subject to, Assembly Bio’s collaboration
agreement governing its activity in the China territory; Assembly
Bio’s ability to maintain financial resources necessary to
continue its clinical trials and fund business operations; any
impact that the COVID-19 pandemic may have on Assembly Bio’s
business and operations, including initiation and continuation of
its clinical studies or timing of discussions with regulatory
authorities; and other risks identified from time to time in
Assembly Bio’s reports filed with the U.S. Securities and
Exchange Commission (the SEC). You are urged to consider statements
that include the words may, will, would, could, should, might,
believes, hopes, estimates, projects, potential, expects, plans,
anticipates, intends, continues, forecast, designed, goal or
the negative of those words or other comparable words to be
uncertain and forward-looking. Assembly Bio 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 Assembly Bio’s risks
and uncertainties are more fully detailed under the heading “Risk
Factors” in Assembly Bio's filings with the SEC, 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 Bio assumes no obligation to update publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Arbutus’ Forward-Looking StatementsThis 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 anticipated trial design of
Assembly Bio’s and Arbutus’ Phase 2 clinical trial; 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
to provide patients with chronic hepatitis B a much needed and
durable functional cure; and expectations regarding the safety and
efficacy of Arbutus’ 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 the Phase 2 clinical trial with
Assembly, 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: the Phase 2 clinical trial may be more costly or take
longer to complete than anticipated, and may never be completed, or
may not generate results that warrant future development; 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
and/or Assembly’s 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 Bio ContactsInvestor ContactAssembly
BioLauren GlaserSenior Vice President, Investor Relations and
Corporate Affairs(415) 521-3828lglaser@assemblybio.com
Media ContactSam Brown Inc.Audra Friis(917)
519-9577ASMBMedia@sambrown.com
Arbutus Contacts Investors and Media:William H.
CollierPresident and CEOPhone: 267-469-0914ir@arbutusbio.com
Pam MurphyInvestor Relations ConsultantPhone:
267-469-0914ir@arbutusbio.com
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