Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology
company developing innovative antiviral therapeutics targeting
serious viral diseases, today announced data from its hepatitis D
virus (HDV) and hepatitis B virus (HBV) antiviral pipeline featured
in five poster presentations at the International Liver
Congress™, the Annual Meeting of the European Association for the
Study of the Liver (EASL) taking place in Vienna, Austria, on June
21-24, 2023, including one selected for inclusion in the Best of
EASL Congress summary.
“We are excited to share the latest data on our promising
HDV/HBV entry inhibitor program and next-generation HBV core
inhibitors with the scientific community,” said William Delaney,
PhD, chief scientific officer of Assembly Bio. “Data presented from
our entry inhibitor program, from which we expect to nominate a
development candidate this year, highlight our rapid progress in
developing a small molecule inhibitor of this validated mechanism.
Additionally, we’re pleased to share results from our recent
clinical studies of 4334 and 3733, which reinforce the ability of
these highly potent, next-generation core inhibitors to lead to
deep reductions in viral replication and the potential to increase
functional cure rates for HBV as part of a combination
regimen.”
HBV/HDV Entry Inhibitor Program HDV is a
satellite virus only found in the presence of HBV, and HDV/HBV
co-infection is considered the most severe form of chronic viral
hepatitis due to faster liver disease progression. A poster
entitled “A novel class of orally available small molecules
potently inhibit hepatitis B and D virus entry” presents insights
on the identification of a novel class of highly potent, orally
bioavailable HBV/HDV entry inhibitors which show nanomolar (nM)
potency, metabolic stability and good oral bioavailability. These
inhibitors interfere with preS1 protein binding and NTCP-mediated
bile acid uptake, reinforcing that the molecular target is NTCP
(sodium taurocholate co-transporting polypeptide, a protein
exclusively expressed on the membrane of hepatocytes). Assembly Bio
anticipates the nomination of a development candidate this
year.
Next-Generation HBV Core Inhibitor Candidates ABI-H3733
and ABI-4334 ABI-H3733 (3733) and ABI-4334 (4334) are
novel, structurally distinct, orally bioavailable investigational
core inhibitors that exhibit nM potency against pgRNA encapsidation
and covalently closed circular (ccc)DNA formation.
The poster entitled “The safety and pharmacokinetics of
ABI-4334, a novel next-generation HBV core inhibitor: interim
results from a Phase 1 study in healthy volunteers” showcases data
from a single (SAD) and multiple ascending dose (MAD)
first-in-human study in healthy volunteers. The therapy was well
tolerated when administered orally up to 400 mg as a single dose or
up to 200 mg once a day for eight days, with no Grade 3 or 4
adverse events (AEs), serious AEs or deaths. Potential for
best-in-class activity is projected, with a once daily dose of 200
mg estimated to achieve 175× the predicted plasma adjusted (pa)
EC50 values for viral replication inhibition and 34× paEC50 for the
prevention of cccDNA formation.
The poster entitled “Safety, pharmacokinetics, and antiviral
activity of the next-generation hepatitis B core inhibitor
ABI-H3733 in patients with hepatitis B e antigen negative chronic
hepatitis B infection: preliminary results from a randomized,
blinded, Phase 1b study” has been selected for inclusion in the
viral hepatitis track hub and to be featured in the Best of EASL
Congress summary. This poster features Phase 1b study data in which
up to 100 mg of 3733 administered daily was shown to be well
tolerated over a 28-day period in patients with chronic HBV (cHBV).
3733 showed increased potency compared to data from studies with
first-generation core inhibitors as evidenced by rapid, multi-log
declines in HBV DNA at low doses and greater proportions of
patients achieving HBV DNA ‘not detected’ by the end of treatment.
All patients in the highest dose group achieved HBV DNA below the
lower limit of quantification by the end of treatment. All AEs and
lab abnormalities were Grade 2 or lower, with no serious AEs,
treatment discontinuations or deaths. The pharmacokinetic profile
and antiviral activity of 3733 reflect the improved potency of
next-generation core inhibitors against both mechanisms of action
and potential to advance finite treatment regimens for patients
with cHBV.
In vitro data presented in the poster entitled “Next generation
core inhibitors ABI-H3733 and ABI-4334 have significantly improved
potency and target coverage for both antiviral and cccDNA formation
activities compared to first-generation core inhibitors” show that
3733 and 4334 are significantly more potent in preventing viral
replication and cccDNA formation compared to the first-generation
core inhibitor, vebicorvir (VBR). Additionally, these data show
that 3733 and 4334 have significantly improved human exposure
coverage for both viral replication and cccDNA formation as
compared with VBR.
Vebicorvir (VBR) Phase 2 Combination Data The
first-generation core inhibitor candidate, VBR, was evaluated in a
Phase 2 study in combination with entecavir (ETV) and pegylated
interferon alpha (Peg-IFNα) in patients with hepatitis B e antigen
positive cHBV infection. Highlighted in a poster entitled
“Vebicorvir, entecavir, and pegylated interferon in patients with
hepatitis B e antigen positive chronic hepatitis B virus infection:
findings from a Phase 2, randomized open-label study in China,” the
data suggest that the addition of Peg-IFNα to VBR and ETV does not
result in significantly greater declines in HBV parameters compared
to the dual agent control arms and is unlikely to result in
significant rates of functional cure following 24 weeks of
treatment. In the study, the all oral VBR+ETV arm performed
similarly to the two Peg-IFNα-containing arms with 6.0 log10 IU/mL
and 0.6 log10 IU/mL reductions in HBV DNA and HBsAg from baseline,
respectively. VBR+ETV demonstrated a favorable safety profile
relative to the Peg-IFNα containing regimens.
Subsequent to presentation at EASL’s International Liver
Congress™ 2023, Assembly Bio intends to make the posters available
on the “Events & Presentations” page in the “Investors” section
of its website at www.assemblybio.com.
About Assembly BiosciencesAssembly
Biosciences is a 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. 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 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; 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 RyanSVP,
Investor Relations, Corporate Affairs and Alliance Management(415)
738-2992sryan@assemblybio.com
Media:Sam Brown Inc. Hannah Hurdle(805)
338-4752ASMBMedia@sambrown.com
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