Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical
stage biopharmaceutical company focused on developing novel
therapeutics to address unmet medical needs in liver and viral
diseases, today announced positive data from six poster
presentations at the European Association for the Study of the
Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.
The clinical poster presentations highlight the continued potent
antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in
both HBeAg-positive and HBeAg-negative subjects.
Data from ≤72 weeks following an oral daily dose of 300 mg
ALG-000184 monotherapy demonstrated sustained HBV DNA suppression
(<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects
with no viral breakthrough. New data also showed that as HBeAg
declined to near negativity in this patient population, anti-HBe
antibody (HBeAb) levels exhibited a positive trend.
Reported for the first time were antiviral and safety data in
HBeAg-negative CHB subjects who received a daily single dose of 300
mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%),
complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA
(<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels
indicating inhibition of HBV replication, as well as inhibition of
cccDNA establishment/replenishment. In both patient populations,
ALG-000184 continues to be well tolerated with no viral
breakthrough.
“We designed ALG-000184 as a highly potent agent that could
deliver broad antiviral efficacy in hepatitis B patients,
regardless of their HBeAg status,” stated Lawrence Blatt, PhD, MBA,
Chairman, President & CEO of Aligos Therapeutics. “These new
data in HBeAg-negative CHB patients complement the broad antiviral
activity we have already reported in HBeAg-positive CHB patients,
with data now up to 72 weeks showing 90% of subjects achieved HBV
DNA suppression. The extent of HBV DNA suppression observed to date
in both CHB patient populations appear to exceed those reported by
the current standard of care nucleos(t)ides, leading us to believe
this is a best/first-in-class molecule.”
Additionally, other preclinical poster presentations demonstrate
the potential of next generation siRNAs for treating metabolic
dysfunction-associated steatohepatitis (MASH) and CHB as well as a
novel CAM-A molecule for the treatment of CHB.
Details of the presentations are as follows:
ALG-000184: Potential best-in-class small molecule CAM-E
for chronic hepatitis B (CHB)
Title: Extended Treatment of HBeAg+ CHB
Subjects with the Capsid Assembly Modulator ALG-000184 with or
without Entecavir is Associated with Reductions in Viral Markers
and Favorable Anti-HBeAb trendsPresenter:
Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the
Division of Gastroenterology and Hepatology, University of Hong
KongDate/Time: June 5, 2024 at 8:30am CEST
Title: Dosing with the Capsid Assembly
Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects
Results in Potent Antiviral Effects Including Suppression of HBV
DNA/RNA and Declines in HBcrAg LevelsPresenter:
Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London),
Consultant Hepatologist and Transplant Physician, Institute of
Liver Studies, King’s College Hospital NHS Foundation
TrustTime: June 5, 2024 at 8:30am CEST
Title: Association of baseline characteristics
and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects
following ALG-000184±ETV treatmentPresenter: Kha
Le, PhDTime: June 5, 2024 at 8:30am CEST
Preclinical
Title: In vitro and in vivo pharmacological
characterization of human PNPLA3-targeting short interfering RNA
molecules for the treatment of metabolic dysfunction-associated
steatohepatitisPresenter: Jieun Song,
PhDTime: June 6, 2024 at 8:30am CEST
Title: Second generation HBV siRNAs with novel
chemistries demonstrate improved profiles compared with ALG-125755
and other clinical stage siRNAsPresenter: Jin
Hong, PhDDate/Time: June 8, 2024 at 8:30am
CEST
Title: Non-HAP CAM-A ALG-006746 and ALG-006780
induce rapid HBsAg reductions in AAV-HBV mice and have favorable
pharmacokinetic profilesPresenter: Yannick Debing,
PhDDate/Time: June 8, 2024 at 8:30am CEST
The presentations can be found on the Scientific
Presentations & Conferences section of the Aligos website
(www.aligos.com) after the live event.
About Aligos
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical
company that was founded in 2018 with the mission to become a world
leader in the treatment of liver and viral diseases. Aligos’
strategy is to harness the deep expertise and decades of drug
development experience its team has in liver and viral diseases to
discover and develop potentially best-in-class therapeutics for
metabolic dysfunction-associated steatohepatitis (MASH) and viruses
with high unmet medical need such as hepatitis B and
coronaviruses.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this press release that are not historical
facts may be considered “forward-looking statements”, including
without limitation, statements regarding Aligos’ financial results
and performance as well as research and development activities,
including regulatory status and the timing of announcements and
updates relating to our regulatory filings and clinical trials.
Such forward looking statements are subject to substantial risks
and uncertainties that could cause our development programs, future
results, performance, or achievements to differ materially from
those anticipated in the forward-looking statements. Such risks and
uncertainties include, without limitation, risks and uncertainties
inherent in the drug development process, including Aligos’
clinical-stage of development, the process of designing and
conducting clinical trials, the regulatory approval processes, and
other matters that could affect the sufficiency of Aligos’ capital
resources to fund operations. For a further description of the
risks and uncertainties that could cause actual results to differ
from those anticipated in these forward-looking statements, as well
as risks relating to the business of Aligos in general, see Aligos’
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 7, 2024 and its future periodic reports
to be filed or submitted with the Securities and Exchange
Commission. Except as required by law, Aligos undertakes no
obligation to update any forward-looking statements to reflect new
information, events or circumstances, or to reflect the occurrence
of unanticipated events.
Investor ContactJordyn TaraziVice President,
Investor Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
Media ContactMichael FitzhughLifeSci
Communicationsmfitzhugh@lifescicomms.com
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