Assembly Biosciences Doses First Subject in Phase 1a Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of Investigational Next Generation Core Inhibitor ABI-4334
15 November 2022 - 12:00AM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative, investigational
therapeutics targeting hepatitis B virus (HBV) and other viral
diseases, today announced that the first subject has been dosed in
the Phase 1a trial of its investigational core inhibitor ABI-4334
(4334).
4334 is an investigational next-generation core inhibitor that
is optimized for significantly increased potency against covalently
closed circular DNA (cccDNA) formation and new virus production
versus first-generation core inhibitors. In preclinical research,
4334 has demonstrated sub-nanomolar potency against pgRNA
encapsidation and 2-3 nanomolar potency against cccDNA formation.
Chronic HBV infection is a debilitating disease of the liver that
is estimated to impact approximately 296 million people worldwide.
HBV is the 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 initiation of this first-in-human clinical trial for our
investigational next-generation core inhibitor 4334, our most
potent core inhibitor, marks a significant milestone in advancing
toward our goal of delivering novel finite and curative therapies
for HBV that target multiple steps during viral replication to
suppress the production of new virus, particularly the formation of
new cccDNA, the viral reservoir,” said Michele Anderson, chief
development officer of Assembly Bio. “Most importantly, this trial
underscores our commitment to addressing critical unmet needs for
patients with HBV as we pursue our mission of making a profound
impact on patients’ lives.”
The Phase 1a clinical trial is a randomized, blinded and
placebo-controlled study that will evaluate the safety,
tolerability and pharmacokinetics of 4334 following single
ascending dose and multiple ascending dose administration in
healthy participants. The objectives of the study include the
proportion of subjects with adverse events (AEs), premature
treatment discontinuation due to AEs and abnormal laboratory
results. Results of the trial will support dose selection for a
future Phase 2 trial.
Additional information about the trial is available at
clinicaltrials.gov using the identifier NCT05569941. Data from the
preclinical research program that supported clinical advancement
for 4334 was recently presented at The Liver Meeting® hosted by the
American Association for the Study of Liver Diseases (AASLD) in a
poster available on Assembly Bio’s website at:
https://investor.assemblybio.com/events/event-details/liver-meeting-2022.
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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