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
Rhea-AI Summary
Aligos Therapeutics (Nasdaq: ALGS) announced that its partner Xiamen Amoytop Biotech has dosed the first participant in a Phase 1 study of ALG-170675, an investigational next-generation antisense oligonucleotide for potential functional cure of chronic hepatitis B virus (HBV) infection. Amoytop is conducting the study in China and holds rights in Greater China.
The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics using single and multiple ascending doses in healthy participants, followed by a cohort of chronic HBV participants. The design includes single-dose cohorts of 75, 150, 300, and 450 mg, a multiple-dose phase, and a chronic HBV cohort expected to start in Q4 2026. ALG-170675, discovered by Aligos under a collaboration with Amoytop, has associated novel intellectual property and has shown improved RNase H–mediated in vivo activity over GSK‑836 (bepirovirsen) with similar hTLR8 agonist activity in preclinical testing, as well as use of novel monomers intended to potentially reduce toxicity and improve liver-to-kidney distribution.
Positive
- First participant dosed in ALG-170675 Phase 1 study in China
- Phase 1 design includes ~32 SAD, ~24 MAD, ~16 HBV participants
- Single ascending dose cohorts planned at 75, 150, 300, 450 mg
- HBV patient cohort expected to initiate in Q4 2026 after MAD 150 mg
- ALG-170675 shows improved RNase H in vivo activity over GSK-836 in preclinical data
- Novel monomers in ALG-170675 designed to potentially reduce ASO toxicity
Negative
- None.
News Explained
The chronic-HBV cohort is not yet underway: it is expected in
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 13 | Phase 2 enrollment | Positive | -3.9% | B-SUPREME enrollment completed across HBeAg-positive and HBeAg-negative cohorts. |
| Apr 14 | Interim trial results | Positive | -15.1% | Interim results reported; futility criteria were not met and Fast Track was granted. |
| Jan 21 | Phase 2 progress | Positive | -0.1% | B-SUPREME enrolled 144 subjects and remained on track for completion. |
| Aug 13 | Phase 2 dosing | Positive | +2.9% | First subject dosing initiated in the 200-subject B-SUPREME study. |
| Oct 15 | Conference data | Positive | +0.6% | Four abstracts accepted for liver-disease clinical and preclinical data presentations. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial announcements produced negative 24-hour reactions in three of five events, including two positive milestones.
Key Terms
antisense oligonucleotide medical
pharmacokinetics medical
pharmacodynamics medical
rnase h technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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
jtarazi@Aligos.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
