Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors at International Herpesvirus Workshop
15 7월 2024 - 9:00PM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company
developing innovative therapeutics targeting serious viral
diseases, today announced new preclinical data from its
investigational herpes simplex virus (HSV) portfolio featured in
three presentations at the International Herpesvirus Workshop
(IHW), taking place July 13-17, 2024, in Portland, Ore.
“We are excited to present promising data from our HSV
helicase-primase inhibitor candidates ABI-5366 and ABI-1179, which
we are rapidly progressing to deliver on our mission of offering
new, effective treatments for people living with chronic viral
diseases,” said Anuj Gaggar, MD, PhD, chief medical officer of
Assembly Bio. “Current treatments for recurrent genital herpes
often fall short in fully managing symptoms and preventing
recurrences, and we are pleased with the potential of our HSV
candidates to provide a different approach, as highlighted in the
data presented at IHW. We continue to advance these candidates and
look forward to sharing further updates with the herpesvirus
community, including interim ABI-5366 Phase 1a first-in-human data
expected in the third quarter of this year.”
Approximately 50% of individuals with initial symptomatic
genital herpes infection have three or more recurrences per year,
including over four million people in the United States and France,
Germany, Italy and Spain (collectively, the EU4), and the United
Kingdom. While genital herpes can be caused by either HSV type 1
(HSV-1) or HSV type 2 (HSV-2), recurrences are more likely to be
experienced by individuals infected by HSV-2. The current standard
of care for recurrent genital herpes are nucleoside analogs;
however, these are only partially effective in preventing
recurrences. Assembly Bio’s HSV antiviral candidates target the HSV
helicase-primase complex, an essential HSV enzyme complex with no
host equivalent, and are designed for long-acting
administration.
A poster entitled “The Helicase-Primase Inhibitor ABI-5366 Is a
Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent
Genital Herpes” highlights preclinical data that supported
ABI-5366’s entry into Phase 1 clinical evaluation. Results
demonstrated that ABI-5366 showed low nanomolar activity against
both HSV-1 and HSV-2, including broad activity against HSV clinical
isolates, and specificity for HSV. ABI-5366 was shown to be
generally non-toxic across a variety of cell types with no
off-target effects observed in vitro or in vivo, including no
activity against carbonic anhydrase esterases. Further, a favorable
in vivo safety profile of ABI-5366 was observed in 28-day oral
toxicity studies in two species, and pharmacokinetic (PK) studies
evaluating ABI-5366 when administered orally or intramuscularly
demonstrated long-acting potential for this compound. The Phase
1a/b study for ABI-5366 was initiated in May 2024 and is currently
enrolling; interim Phase 1a data are expected in Q3 2024 and
interim Phase 1b data are expected in the first half of 2025.
Additionally, an oral and poster presentation entitled
“Preclinical Characterization of ABI-1179, a Potent Helicase
Primase Inhibitor for the Treatment of Recurrent Genital Herpes”
features preclinical data from ABI-1179, a structurally distinct,
long-acting helicase-primase inhibitor candidate, licensed from
Gilead Sciences, Inc. (Gilead) under the collaboration between
Assembly Bio and Gilead. ABI-1179 has demonstrated low nanomolar
activity across HSV-1 and HSV-2 lab strains and clinical isolates,
including acyclovir-resistant isolates. In resistance selection
studies, ABI-1179 displayed a higher barrier to resistance
development than acyclovir. Furthermore, ABI-1179 demonstrated
antiviral activity against some HSV-2 strains harboring mutations
known to confer resistance to other helicase-primase inhibitors. In
a preclinical study, ABI-1179 demonstrated a favorable PK profile
that supports the evaluation of once-weekly oral dosing. Further,
in a preclinical model of recurrent HSV infection, ABI-1179
significantly reduced the development of recurrent lesions.
Assembly Bio expects to initiate a Phase 1a/b first-in-human study
of ABI-1179 by the end of 2024.
Assembly Bio intends to make the presentations available on the
“Events & Presentations” page in the “Investors” section of its
website at www.assemblybio.com. The investigational product
candidates ABI-5366 and ABI-1179 have not been approved anywhere
globally, and their safety and efficacy have not been
established.
About Assembly Biosciences Assembly Biosciences
is a biotechnology company dedicated to the development of
innovative small-molecule therapeutics designed to change the path
of serious viral diseases and improve the lives of patients
worldwide. Led by an accomplished team of leaders in virologic drug
development, Assembly Bio is committed to improving outcomes for
patients struggling with the serious, chronic impacts of
herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus
(HDV) infections. 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 realize the potential benefits
of its collaboration with Gilead Sciences, Inc., including all
financial aspects of the collaboration and equity investments;
Assembly Bio’s ability to initiate and complete clinical studies
involving its therapeutic product candidates, including studies
contemplated by Assembly Bio’s collaboration with Gilead, in the
currently anticipated timeframes or at all; safety and efficacy
data from clinical or nonclinical 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; 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) 738-2992investor_relations@assemblybio.com
Media:Sam Brown Inc.Hannah Hurdle(805)
338-4752ASMBMedia@sambrown.com
Assembly Biosciences (NASDAQ:ASMB)
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Assembly Biosciences (NASDAQ:ASMB)
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