Multiple Abstracts Highlighting Assembly Biosciences’ Hepatitis B Core Inhibitor Development Programs Accepted for Presenta...
November 02 2020 - 8:00AM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV) and diseases associated with the
microbiome, announced that data from its HBV core inhibitor
research and development programs as well as a collaborative
translational study using Assembly Bio’s sensitive HBV nucleic acid
assays are featured in four abstracts accepted for presentation
during The Liver Meeting Digital Experience™ (TLMdX). This annual
meeting of the American Association for the Study of Liver
Diseases (AASLD) will be hosted virtually November 13-16,
2020.
TLMdX Poster
PresentationsPosters are expected to be made
available to conference registrants through the online AALSD portal
at the start of the meeting on the morning of Friday, November 13,
and will be available subsequently on the “Events &
Presentations” page in the “Investors” section of Assembly's
website at www.assemblybio.com.
- Poster
#820: Analysis of the
longer-term safety profile of the hepatitis B virus core inhibitor
ABI-H0731 (vebicorvir) in an open-label extension
studyPresenter: Ira M. Jacobson, MD, Director,
Hepatology, NYU Langone Health
- Poster #738:
Persistently detectable serum HBV pgRNA is associated with
subsequent HCC development in chronic hepatitis B patients
receiving chronic NrtI treatmentPresenter: Lung-Yi
Mak, MBBS, MRCP, PDipID, FHKCP, FHKAM Department of Medicine, Queen
Mary Hospital, The University of Hong Kong, Hong Kong
- Late Breaking Poster
LP37: Changes in viral antigens
are more strongly associated with HBV pgRNA than HBV DNA in studies
of vebicorvir and NrtI in treatment-naive patients with chronic HBV
infectionPresenter: Mark Sulkowski, MD, Medical
Director, Viral Hepatitis Center, Johns Hopkins University School
of Medicine
- Late Breaking Poster
LP45: Amino acid substitutions in
the inhibitor binding pocket of HBV core protein confer
differential changes in susceptibility to three generations of HBV
core inhibitorsPresenter: Dawei Cai, PhD, Senior
Scientist, Assembly Biosciences
About Assembly Biosciences’ HBV Core Inhibitor
PortfolioAssembly 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, or 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 Bio has begun transitioning patients off
therapy, to then monitor for sustained virologic response
(SVR).
Assembly Bio’s HBV portfolio also includes two more potent,
second-generation candidates ABI-H2158 in Phase 2 development, and
ABI-H3733, in Phase 1 development.
Vebicorvir and ABI-H2158 both have been granted Fast Track
designation by the U.S. Food and Drug Administration for
the treatment of chronic HBV infection.
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 viral replication, resulting in very
low cure rates. There is a significant unmet need for new therapies
to treat HBV.
About Assembly BiosciencesAssembly
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 Bio’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.
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 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; Assembly Bio may not
observe sustained virologic response in patients who stop
therapy in Study 211; Assembly Bio’s ability to maintain financial
resources necessary to continue its clinical trials and fund
business operations; any impact that the spread of the coronavirus
and resulting COVID-19 pandemic may have on Assembly Bio’s business
and operations, including initiation and continuation of its
clinical trials 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.
ContactsAssembly Biosciences, Inc.Lauren
GlaserSenior Vice President, Investor Relations and Corporate
Affairs(415) 521-3828lglaser@assemblybio.com
Media ContactSam Brown Inc. Audra Friis (917) 519-9577
ASMBMedia@sambrown.com
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