Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company
developing innovative antiviral therapeutics targeting serious
viral diseases, today provided an update of results from the final
multiple-dose cohort in the ongoing Phase 1a study of its
investigational next-generation, highly potent hepatitis B virus
(HBV) core inhibitor, ABI-4334 (4334), and announced it will
evaluate partnering opportunities for its core inhibitor portfolio
and prioritize its expanded virology pipeline.
“We are encouraged by the promising clinical profile of our most
potent core inhibitor candidate, 4334, and its potential to reach
the clinical exposures needed for both potent antiviral activity
and inhibition of cccDNA formation,” said Jason Okazaki, chief
executive officer and president of Assembly Bio. “While we are
enthusiastic about these results and the antiviral activity shown
in our Phase 1b study of our other next-generation core inhibitor,
3733, in HBV patients, we recognize that demonstrating the ability
of next-generation core inhibitors to inhibit cccDNA formation in
the clinic, which we view as a critical part of HBV cure, will
require longer-duration Phase 2 studies. Because of this, we
believe partnering our core inhibitor portfolio would enable
additional opportunities for further clinical development for this
compelling mechanism aimed at achieving a functional cure for HBV,
including opening up other avenues for combination approaches.”
“We are prioritizing our expanded virology pipeline because we
believe these programs offer higher potential to have a near-term
impact for patients and stockholders,” continued Mr. Okazaki. “Over
the past three years, we have built a strategically diverse
portfolio designed to address significant unmet medical needs with
shorter timelines to key inflection points and clinical proof of
concept than our core inhibitor portfolio. To that end, we
anticipate entering the clinic with the first of these program
candidates, the long-acting helicase inhibitor ABI-5366 for
treatment of high-recurrence genital herpes, during the first half
of 2024 and look forward to moving a second program candidate into
the clinic by the end of 2024.”
Assembly Bio’s expanded virology research pipeline unveiled in
2022 focuses on differentiated programs against validated clinical
targets for HBV/hepatitis delta virus (HDV) and herpesviruses. With
the reprioritization of programs, Assembly Bio’s estimated cash
runway extends into the third quarter of 2024.
4334 Clinical Data and Development UpdateThe
Phase 1a clinical trial for 4334 (Study ABI-4334-101) is a
randomized, blinded and placebo-controlled study evaluating the
safety, tolerability and pharmacokinetics (PK) of 4334 following
single ascending dose and multiple ascending dose administration in
healthy subjects. The objectives of the study include assessment of
the proportion of subjects with adverse events (AEs), premature
treatment discontinuation due to AEs and abnormal laboratory
results.
Dosing has been completed for all subjects in all four
single-dose cohorts (30 mg, 100 mg, 200 mg and 400 mg), two
multiple-dose cohorts of 100 mg and 200 mg and one food effect
cohort at 200 mg (with data pending for the food effect
cohort).
Based on data available for the single-dose and multiple-dose
cohorts through April 17, 2023, 4334 continued to show a half-life
supportive of once-a-day (QD) dosing. In addition, based on PK data
from these cohorts and preclinical studies, daily minimum plasma
trough concentrations (Cmin) are projected to achieve double-digit
multiples over protein-adjusted EC50 for both antiviral activity
and against cccDNA formation within the dose range studied in the
Phase 1a study, with the 200 mg QD dose projected to achieve >30
times the protein-adjusted EC50 for cccDNA formation.
Through April 17, 2023, treatment-emergent AEs and laboratory
abnormalities were mild to moderate with the majority being mild,
and there were no patterns of AEs or laboratory abnormalities noted
to be associated with 4334 and no clinically significant ECG
abnormalities reported.
4334 was internally discovered and developed by Assembly Bio and
designed to optimize potency against both new virus production and
formation of cccDNA, the viral reservoir.
About Assembly BiosciencesAssembly
Biosciences is a clinical-stage biotechnology company dedicated to
the development of innovative small molecule antiviral therapeutics
designed to change the path of serious viral diseases and improve
the lives of patients worldwide. The company’s hepatitis B virus
(HBV) and hepatitis delta virus (HDV) pipeline includes two
complementary approaches, a viral entry inhibitor and an oral,
liver-focused, interferon-alpha receptor agonist, with potential
application for both HBV and as chronic suppressive therapy for
HDV, which is associated with significantly increased disease
burden for HBV/HDV patients. The herpesvirus pipeline addresses two
serious consequences associated with herpesvirus infections,
high-recurrence genital herpes and transplant-associated
herpesviruses. The company is also evaluating partnering options to
further clinical development of its potent, next-generation HBV
core inhibitors designed to disrupt the virus’ replication cycle at
several key points with the aim of achieving finite treatment and
functional cures. 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 HBV, HDV and herpesvirus 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 maintain financial resources
necessary to continue its clinical studies and fund business
operations; 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 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; 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; 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.
Contacts
Investor and Corporate: Shannon
Ryan SVP, Investor Relations, Corporate Affairs and Alliance
Management (415)
738-2992 sryan@assemblybio.com
Media: Sam Brown Inc. Hannah
Hurdle (805) 338-4752 ASMBMedia@sambrown.com
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