Assembly Biosciences Presents New Data at AASLD The Liver Meeting® Highlighting Breadth of Virology Portfolio and Potential of Next-Generation Core Inhibitors in HBV
November 04 2022 - 8:00AM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative, investigational
therapeutics targeting hepatitis B virus (HBV) and other viral
diseases, today reported clinical and preclinical data from its
virology portfolio at the American Association for the Study of
Liver Diseases (AASLD), The Liver Meeting®. The new data are being
presented at the conference as part of four poster presentations,
including two late breaker presentations.
“The data presented at AASLD’s The Liver Meeting demonstrate the
significant progress that we are making in advancing and broadening
our early-stage virology programs. These presentations highlight
the strength of our research capabilities and the deep virology
experience across the team,” said William Delaney, PhD, chief
scientific officer of Assembly Bio. “Preclinical data presented
from our 4334 program further demonstrate and detail the activity
of this next-generation core inhibitor that has been optimized for
significantly increased potency against cccDNA formation.
Additionally, the first presentation of preclinical data from our
small molecule HBV/HDV entry inhibitor and IFNAR agonist programs
provides support for our continued advancement of these approaches
toward clinical development. We remain committed to our goal of
discovering and developing novel antivirals that change the
treatment paradigm for serious viral diseases. We are particularly
focused on the urgent need for curative and finite therapies for
chronic hepatitis B patients and better treatment options for
patients chronically infected with HDV.”
In the poster entitled “ABI-4334, a novel hepatitis B core
inhibitor, accelerates capsid assembly and inhibits cccDNA
formation via multiple pathways,” preclinical data are
presented that further demonstrate and detail the core inhibitor
activity of ABI-4334 (4334) against pgRNA encapsidation and
covalently closed circular DNA (cccDNA) formation. These activities
were demonstrated to be due in part to the ability of 4334 to both
accelerate formation of empty capsids as well as prematurely
disrupt intact capsids. 4334 demonstrates low or subnanomolar
potency against both DNA replication and cccDNA formation, with
EC50 concentrations well below the predicted minimum plasma
concentration. Further, this study represents the first time in
which a core inhibitor has demonstrated the unique ability to
prematurely disrupt capsids containing DL-DNA, which has the
potential to impact HBV integration. These data support the
advancement of 4334 into Phase 1 clinical studies.
A novel class of highly potent, orally bioavailable HBV and HDV
entry inhibitors is highlighted in the poster entitled “Preclinical
Characterization of a Novel Class of Highly Potent Small Molecule
Hepatitis B and D Virus Entry Inhibitors.” This class of compounds
exhibit nanomolar activity in vitro to inhibit HBV and HDV
infection in hepatic cells. Further, these compounds have
demonstrated an ability to inhibit preS1 binding to NTCP, the
functional receptor for HBV and HDV uptake, and to inhibit
NTCP-mediated bile acid uptake, further supporting that they target
NTCP. In preclinical pharmacokinetic (PK) studies, this class of
molecules demonstrate favorable PK properties including high
permeability and bioavailability and potential for once daily
dosing in patients. Lead optimization for this series is in
progress at Assembly Bio, with candidate nomination anticipated in
2023.
In the late-breaking poster entitled “Preclinical
characterization of a novel liver-focused small molecule
efficiently inhibiting hepatitis B virus by activating type I
interferon signaling,” data is focused on a novel class of orally
bioavailable interferon-alpha receptor (IFNAR) agonists that
efficiently inhibit HBV as well as other viruses. Unlike core
inhibitors or entecavir, these compounds inhibit HBsAg production
whether administered before infection or after the establishment of
cccDNA. The agonists were shown to activate IFNa signaling via the
JAK–STAT pathway, leading to induction of interferon-stimulated
genes. Additionally, preliminary data suggest that this class of
compounds can induce long-lasting antiviral effects when cells were
exposed to compounds for even brief periods of time (15 minutes).
PK studies demonstrate that these agonists have good oral
bioavailability and the half-life can be modulated based on
structure. Lead optimization of multiple agonists is in
progress.
Clinical results from the study evaluating first-generation core
inhibitor vebicorvir (VBR) in combination with Arbutus Biopharma’s
AB-729 in HBV are presented in the late-breaking poster
entitled “Evaluation of the vebicorvir, NrtI, and AB-729
combination in virologically suppressed patients with HBeAg
negative chronic hepatitis B virus infection: Interim analysis from
an open label phase 2 study.” Data from this clinical trial
indicate that all regimens tested were generally well tolerated.
The interim data further suggest that the addition of VBR to AB-729
plus treatment with a nucleos(t)ide reverse transcriptase inhibitor
(NrtI) does not result in notably greater on-treatment improvements
in markers of active HBV infection compared with AB-729+Nrtl. No
patient achieved HBsAg loss or HBsAg seroconversion during the
48-week on-treatment period.
AASLD Presentations and
PostersPresentations and posters are expected to be made
available online to conference registrants through The Liver
Meeting Digital Experience™ at
https://www.aasld.org/the-liver-meeting/digital-experience within
72 hours of presentation. The full posters are also now available
online at the “Events & Presentations” page in the
“Investors” section of Assembly's website
at www.assemblybio.com.
About Assembly BiosciencesAssembly Bio is
a clinical-stage biotechnology company pioneering the development
of novel therapeutics for serious viral diseases. Assembly Bio is
advancing a leading portfolio of more potent, next-generation core
inhibitor drug candidates that aim to break the complex viral
replication cycle of hepatitis B virus (HBV) to achieve finite and
potentially curative therapies for the 296 million people living
with HBV worldwide. The company’s research pipeline includes
differentiated antiviral approaches against HBV/hepatitis delta
virus and herpesviruses. For more information,
visit assemblybio.com.
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 successfully execute its
previously announced reprioritization and restructuring activities,
including the CEO transition; potential adverse legal,
reputational, operational and financial effects on Assembly Bio
resulting from the reprioritization and restructuring activities;
Assembly Bio’s ability to initiate and complete clinical studies
involving its therapeutic product candidates, including studies
contemplated by Assembly Bio’s 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; results of nonclinical
studies may not be representative of disease behavior in a clinical
setting and may not be predictive of the outcomes of clinical
studies; continued development and commercialization of ABI-H3733,
if successful, in the China territory will be dependent on, and
subject to, Assembly Bio’s collaboration agreement governing this
activity in the China territory; Assembly Bio’s ability to maintain
financial resources necessary to continue its clinical studies and
fund business operations; any impact that the COVID-19 pandemic may
have on Assembly Bio’s business and operations, including
initiation, enrollment 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.
ContactsInvestor and
Corporate:Shannon RyanSVP, Investor Relations, Corporate
Affairs and Alliance Management(415)
738-2992sryan@assemblybio.com
Media:Sam Brown Inc. Hannah
Hurdle (805) 338-4752 ASMBMedia@sambrown.com
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