Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.
2024年7月22日 - 10:00PM
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 that it has entered into a clinical trial
collaboration agreement with Xiamen Amoytop Biotech Co., Ltd.
(“Amoytop”).
Under the terms of the agreement, Amoytop will sponsor and
perform a Phase 1b exploratory clinical study evaluating the
efficacy and safety of ALG-000184 in combination with PEGBING®
(Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in
China. The clinical study is expected to begin after approval by
the National Medical Products Administration in China.
“We are pleased to build on our existing relationship with
Amoytop, as they have proven to be a valuable partner,” stated
Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief
Executive Officer at Aligos Therapeutics. “We look forward to
initiating this exploratory study to evaluate the combination of
ALG-000184 with PEGBING®, one of the approved drugs for CHB
patients in China, to assess the potential benefits of a
combinatory approach.”
ALG-000184 is a potent best/first-in-class oral small molecule
capsid assembly modulator (CAM-E) being developed for CHB. It is
designed to exploit the dual role of CAMs by disrupting hepatitis B
cccDNA levels and its derived transcripts by reducing expression of
viral markers such as DNA, RNA, and the relevant antigens (HBsAg,
HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and
multiple daily doses that ALG-000184 was well-tolerated, with no
safety signals observed, and demonstrated linear pharmacokinetics
(PK) and excellent antiviral activity. In longer term Phase 1b
studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV),
ALG-000184 monotherapy has demonstrated best-in-class reductions in
HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough
to date.
PEGBING®, independently developed by Amoytop, is the world's
first 40kD pegylated interferon α-2b injection. With dual effects
of inhibiting viral replication and enhancing immunity, PEGBING® is
mainly used in the clinical treatment of viral hepatitis and is the
first-line drug for the antiviral treatment of chronic hepatitis B,
which plays an important role in improving the clinical cure rate
of hepatitis B and reducing the risk of liver cancer.
“We are pleased to deepen our cooperation in the field of liver
disease treatment and look forward to working together to provide a
new treatment solution for patients in need,” said Sun Li, Chairman
and Chief Executive Officer at Amoytop. “Amoytop is committed to
further optimizing the chronic hepatitis B combination treatment
pathway and hopes that the cooperation will lead to better clinical
value drugs and drug combinations.”
The Phase 1b study will be a randomized, double blinded, active
controlled study to evaluate the safety, pharmacokinetics, and
antiviral activity of oral once daily doses of 300 mg ALG-000184 +
PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or
PEGBING® + ETV in treatment naïve or currently-not-treated
HBeAg-positive and nucleos(t)ide analog (NA) suppressed
HBeAg-negative subjects with CHB for 48 weeks.
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.
For more information, please visit www.aligos.com or follow us
on LinkedIn or X.
About Xiamen Amoytop Biotech Co., Ltd. Xiamen
Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical
company and a listed company on the Science and Technology
Innovation Board (SSE STAR Market) in China, specializing in
R&D, manufacturing and marketing of regular and long-acting
recombinant protein drugs. Focusing on the R&D of
immune-related cytokine medicines, Amoytop is committed to becoming
a leader in solving cytokine medicine-based systemic immune
problems, providing better solutions for major diseases (such as
viral hepatitis, malignant tumors) and immunotherapy.
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.
Aligos
Therapeutics
Investor Contact Jordyn TaraziVice President,
Investor Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
Media Contact Michael FitzhughLifeSci
Communicationsmfitzhugh@lifescicomms.com
Xiamen Amoytop Biotech Co., Ltd.
Investor Contact Liu
Peiyu联系电话:86592-6889118邮箱:ir@amoytop.com
Media Contact
Wu
Xueyan联系电话:86592-6889127邮箱:wxy@amoytop.com
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