Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones
05 January 2022 - 12:00AM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV) and other viral diseases, today outlined
anticipated progress and milestones for its development pipeline in
2022.
“The forward momentum we expect to demonstrate across our
R&D portfolio in the New Year is indicative of the strength of
our refined strategy and the deep HBV and virologic drug
development expertise and knowledge our team possesses,” said John
McHutchison, AO, MD, chief executive officer and president of
Assembly Bio. “Over the coming months, we plan to share preliminary
on-treatment data from three Phase 2 triple combination studies of
our lead investigational core inhibitor candidate, vebicorvir
(VBR), with other complementary mechanisms; advance the clinical
development of ABI-H3733; and initiate a first-in-human clinical
trial of ABI-4334, our newest core inhibitor candidate, with the
most potent preclinical profile to date. In addition, later this
year we will be announcing exciting new programs to explore and
advance novel antiviral mechanisms in HBV and other viruses. We
look forward to the opportunities and promise 2022 holds – not only
for Assembly Bio, but also for the patients we aim to serve.”
Anticipated Milestones and Events
1H 2022
- Provide updates on strategy and research programs beyond HBV
core inhibition to other HBV targets and share plans to explore
other viruses
- Complete enrollment for the two ongoing triple combination
studies with VBR + NrtI and AB-729, Arbutus Biopharma’s RNAi
therapeutic candidate, and with VBR + NrtI + PEG-IFNα
- Initiate triple combination cohort with VBR + NrtI and
ATI-2173, Antios Therapeutics’ investigational active site
polymerase inhibitor nucleotide (ASPIN)
- Initiate Phase 1b study of ABI-H3733 in patients with chronic
HBV infection
2H 2022
- Initiate first-in-human Phase 1a study of ABI-4334, a
next-generation core inhibitor optimized for potency against the
formation of covalently closed circular DNA (cccDNA)
- Report interim on-treatment data from two triple combination
studies: (1) VBR + NrtI and AB-729 and (2) VBR + NrtI and
interferon (Peg-IFNα)
- Report initial on-treatment data from triple combination cohort
with VBR + NrtI and ATI-2173
- Report initial Phase 1b data for ABI-H3733
- Phase 1a data for ABI-4334 expected as early as year end
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 includes a leading portfolio of more potent,
next-generation core inhibitors, proof-of-concept combination
studies for HBV cure and research programs focused on the discovery
of additional novel antiviral mechanisms for HBV, and other viral
diseases. 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
studies involving its therapeutic product candidates, including
studies 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;
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 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
HBV-related 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:Lauren
GlaserSenior Vice President, Investor Relations and Corporate
Affairs(415) 521-3828lglaser@assemblybio.com
Media:Sam Brown Inc. Audra Friis (917)
519-9577 ASMBMedia@sambrown.com
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