Press Releases August 12, 2026 04:05 PM

Aligos Therapeutics Announces First Participant Dosed in the Phase 1 Study of its Potentially Best-in-Class Antisense Oligonucleotide ALG-170675 by its Partner Amoytop in China

Aligos Therapeutics Initiates Phase 1 Study Dosing of Next-Gen HBV Treatment ALG-170675 in China with Partner Amoytop

By Hana Yamamoto
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Aligos Therapeutics announced the successful dosing of the first participant in the Phase 1 clinical trial of ALG-170675, a next-generation antisense oligonucleotide aimed at functional cure for chronic hepatitis B virus infection. The study is being conducted in China by their partner Amoytop, who holds rights in Greater China. ALG-170675 has demonstrated promising preclinical data, including optimized RNA inhibition and immuno-activation potential, and is expected to advance to dosing in chronic HBV patients by Q4 2026. The trial will evaluate safety, tolerability, and pharmacokinetics across ascending dose cohorts in healthy volunteers before moving to target patients. This milestone represents a significant step forward in Aligos' efforts to develop best-in-class therapies for liver diseases and viral infections.

Aligos Therapeutics Announces First Participant Dosed in the Phase 1 Study of its Potentially Best-in-Class Antisense Oligonucleotide ALG-170675 by its Partner Amoytop in China
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Key Points

  • Initiation of Phase 1 clinical trial dosing for ALG-170675 in China by partner Amoytop.
  • ALG-170675 is designed as a next-generation antisense oligonucleotide offering potential improvements in efficacy and safety over existing therapies for chronic HBV.
  • Planned progression includes single and multiple ascending dose studies in healthy subjects, followed by dosing in chronic HBV patients by Q4 2026.
  • The collaboration underscores focus on combining ALG-170675 with other therapies, such as interferons and capsid assembly modulators, to enhance functional cure rates.
  • ALG-170675 has been optimized for both HBsAg RNA inhibition and immuno-activation
  • Single and multiple ascending doses planned
  • Study will allow rapid advancement into participants with chronic HBV infection in Q4 2026

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing has been initiated in the Phase 1 study of ALG-170675, an investigational next-generation antisense oligonucleotide (ASO) being evaluated for functional cure in the treatment of chronic hepatitis B virus (HBV) infection. The study is being conducted in China by Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”), who maintain rights in Greater China.

“Dosing the first subject in the Phase 1 study of ALG-170675 represents a significant milestone for Aligos and reflects our commitment to advancing potentially best-in-class therapies for patients living with chronic HBV infection,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Despite currently available treatments, chronic HBV infection remains a major global health challenge, with millions of patients at risk of developing cirrhosis, liver failure, and hepatocellular carcinoma. ALG-170675 was designed as a next-generation antisense oligonucleotide with the potential to enhance functional cure rates for patients living with chronic HBV infection, and its advancement into clinical development represents an important step toward that goal. We are highly appreciative of the exceptional efforts of our partner Amoytop, whose expertise, commitment, and efficient execution have enabled the rapid advancement of ALG-170675 into the clinic in China. We look forward to continuing our successful collaboration as the study progresses, including the planned evaluation of ALG-170675 in participants with chronic HBV infection later this year. Looking ahead, we believe there is potential to further improve functional cure rates through combination regimens that may include Amoytop’s pegylated interferon alfa product, PEGBING®, as well as pevifoscorvir sodium, our potentially best-in-class capsid assembly modulator licensed to Amoytop in Greater China. Together, these programs underscore our shared commitment to advancing innovative therapies that address the substantial unmet needs of patients living with chronic HBV infection worldwide.”

ALG-170675 is a next-generation ASO discovered by Aligos as part of a research collaboration with Amoytop, who retain rights in Greater China. Novel intellectual property has been filed for this drug candidate, which has shown improved RNase H mediated in vivo activity over GSK-836 (bepirovirsen) with similar hTLR8 agonist activity observed in vitro and in vivo. In addition, ALG-170675 utilizes novel monomers that could potentially reduce ASO toxicity and improve ASO liver to kidney ratios.

“We are pleased to have initiated dosing in the Phase 1 study of ALG-170675 in China, marking an important step in the clinical development of this promising investigational therapy for chronic HBV infection,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “This milestone reflects the strong collaboration between Amoytop and Aligos, as well as our shared commitment to advancing innovative therapies to address the significant unmet need for patients living with chronic HBV infection.”

The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALG-170675 following single (SAD) and multiple (MAD) ascending doses. The SAD portion plans to enroll approximately 32 healthy participants across four dose cohorts of 75 mg, 150 mg, 300 mg, and 450 mg. Following completion of the 300 mg SAD cohort, the MAD portion of the study is expected to begin and would enroll approximately 24 healthy participants. The study design also includes a cohort of approximately 16 participants with chronic HBV infection, which is expected to initiate following completion of the 150 mg MAD cohort in Q4 2026. For more information, please visit the Chinese Clinical Trial Register.

About Aligos

Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics with high unmet medical needs such as chronic hepatitis B virus (HBV) infection.

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 Statement

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 about the timing, enrollment and potential outcome of ALG-170675 clinical studies including the current Phase 1 study; the potential of ALG-170675 to enhance functional cure rates among chronic HBV patients, including in combination with other regimens; the potential for ALG-170675 to reduce ASO toxicity and improve ASO liver to kidney ratios; and statements regarding Aligos’ mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Such forward-looking statements are subject to substantial risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, the risk that Aligos’ collaborators may fail to successfully develop product candidates under collaboration agreements with Aligos, and risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials and the regulatory approval processes. 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 August 6, 2026 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
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
(650) 910-0427
[email protected]

Xiamen Amoytop Biotech Co., Ltd.

Investor Contact
Liu Peiyu
联系电话:86592-6889118
邮箱:[email protected]

Media Contact
Wu Xueyan
联系电话:86592-6889127
邮箱:[email protected]


Risks

  • Clinical development risks include potential failure to demonstrate safety and efficacy in ongoing and future studies.
  • Risks related to collaboration dependency on partner Amoytop for successful development and commercialization in Greater China.
  • Uncertainties in regulatory approval processes and potential delays impacting timelines and market entry.

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