Aligos Therapeutics Presents Positive Data at The Liver Meeting® 2025

Rhea-AI Summary

Aligos Therapeutics (NASDAQ: ALGS) presented positive clinical and preclinical data for pevifoscorvir sodium (ALG-000184) and its active moiety ALG-001075 at The Liver Meeting® 2025 (Nov 7–11, 2025).

Key clinical results: in Phase 1 monotherapy, 300 mg daily pevifoscorvir produced rapid, durable HBV DNA suppression with 100% (10/10) HBeAg+ subjects 100% (11/11) HBeAg- subjects 75% (6/8) HBeAg+ and 100% (8/8) HBeAg- maintained HBV DNA

Positive

• HBeAg+ HBV DNA 100% (10/10) at Week 96
• HBeAg- HBV DNA 100% (11/11) by Week 24
• No viral breakthrough observed through 96 weeks
• Post-treatment maintenance: 100% (8/8) HBeAg- maintained over 8 weeks
• Preclinical ALG-001075 prevents cccDNA formation and DNA integration in vitro

Negative

• Small Phase 1 cohorts: results from 10–11 subjects limit generalizability

Insights

HBV clinical development analyst

Phase 1 96-week monotherapy data show durable HBV DNA suppression and biomarkers suggest cccDNA impact; tolerability reported as favorable.

Daily 300 mg pevifoscorvir sodium produced rapid, durable HBV DNA declines with no viral breakthrough through Week 96. In HBeAg+ cohorts, HBV DNA < LLOQ rose from 60% at Week 48 to 100% at Week 96; 50% reached undetectable (TND) at Week 96. HBeAg- subjects reached HBV DNA < LLOQ in all participants by Week 24, with 89% undetectable at Week 96. No viral breakthrough was observed and tolerability was described as favorable.

The program also reports post-treatment maintenance of viral suppression during an 8-week NA-only follow-up (75% HBeAg+ and 100% HBeAg- maintained HBV DNA < LLOQ). Preclinical in vitro data indicate ALG-001075 can prevent cccDNA formation and HBV DNA integration. These points link antiviral potency to a plausible secondary mechanism affecting the cccDNA reservoir, but clinical confirmation beyond 8 weeks is needed.

Key dependencies and risks include confirmation of reservoir reduction in larger cohorts and longer post-treatment follow-up. Monitor completion and readouts from the Phase 2 B-SUPREME study and durability beyond the 8-week NA follow-up; expect meaningful milestones over the next 6–24 months.

Oral presentation of 96-week treatment and post-treatment data suggest best-in-class potential of pevifoscorvir sodium

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive data from eight presentations, including one oral presentation, at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting^® 2025, being held November 7 – 11, 2025 in Washington, D.C.

The oral and poster presentations highlighted the best-in-class potential of pevifoscorvir sodium, a potent CAM-E under development for the treatment of chronic hepatitis B virus (HBV) infection.

Pevifoscorvir Sodium Post Treatment Data

Newly presented data highlight outcomes for treatment-naïve or currently not treated HBeAg+ and HBeAg- subjects who completed 96 weeks of 300 mg pevifoscorvir sodium monotherapy, followed by 8 weeks of nucleos(t)ide analog (NA) monotherapy. Among HBeAg+ subjects, 8 of 10 subjects transitioned to NA monotherapy; of these, 6 (75%) maintained HBV DNA levels below the lower limit of quantification (LLOQ; 10 IU/mL, target detected [TD] or target not detected [TND]) throughout the NA only 8-week follow-up period. In the HBeAg- subjects, 8 of 9 subjects switched to NA monotherapy, and all 8 (100%) subjects maintained HBV DNA < LLOQ (10 IU/mL, TD or TND) throughout the NA only 8-week follow-up period. Reductions in HBV antigen and HBV RNA were also maintained during the NA-only 8-week follow-up period. Notably, these viral biomarkers, such as HBV antigens and HBV RNA, are typically unaffected by NA therapy, suggesting that pevifoscorvir sodium may reduce the cccDNA pool through engagement of its secondary mechanism of action.

Additionally, preclinical in vitro data demonstrated that ALG-001075, the active parent moiety of pevifoscorvir sodium, can prevent cccDNA formation and HBV DNA integration. This finding is further supported by cell-based studies presented at the meeting, which showed prevention of cccDNA establishment and HBV DNA integration following treatment with ALG-001075 (Poster #1251).

96 Week Pevifoscorvir Sodium Monotherapy Data

Additionally, the complete 96-week data from the Phase 1 monotherapy (NCT04536337) cohorts were presented showing the continued potential of pevifoscorvir sodium to become first-line therapy for chronic suppression.

In all 10 HBeAg+ subjects with very high mean baseline HBV DNA level of 8.0 log₁₀ IU/mL, a rapid, profound, and durable HBV DNA reduction was noted following daily oral dose of 300 mg pevifoscorvir sodium monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, TD or TND). With treatment extension, this rate increased to 10 of 10 subjects (100%) at Week 96. Additionally, HBV DNA level declined below the undetectable level (< LLOQ (TND, ≤4.29 IU/mL)) in 5 of 10 (50%) subjects at Week 96.

In HBeAg- subjects receiving daily dose of 300 mg pevifoscorvir sodium monotherapy, all 11 (100%) had rapid decline in HBV DNA levels < LLOQ (TD or TND) by Week 24 with HBV DNA suppression maintained for up to 96 weeks of treatment; further decline in 8 of 9 (89%) subjects below the undetectable level of HBV DNA to < LLOQ (10 IU/mL, TND) was noted at Week 96.

Importantly, no viral breakthrough was observed in any subjects receiving pevifoscorvir sodium monotherapy for up to 96 weeks. Furthermore, concurrent multi-log₁₀ reductions in HBV antigens (HBsAg, HBeAg, and HBcrAg) in HBeAg+ subjects and HBcrAg decline in HBeAg- subjects were observed, suggesting the potential inhibition of cccDNA establishment by CAM-E secondary mechanism of action of pevifoscorvir sodium. A favorable tolerability profile was observed in both HBeAg+ and HBeAg- subjects receiving 300 mg pevifoscorvir sodium for up to 96 weeks.

“We are pleased to present these data at this year’s The Liver Meeting, including our first oral presentation on pevifoscorvir sodium,” said Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and CEO of Aligos Therapeutics. “Our results continue to demonstrate the first-in-class and best-in-class potential of pevifoscorvir sodium, with post-treatment Phase 1 data suggesting a significant impact on the cccDNA reservoir in chronic HBV infection. The sustained responses observed after transitioning to standard-of-care therapy reinforce our belief that pevifoscorvir sodium affects the entire HBV lifecycle. We look forward to sharing further data as we advance the Phase 2 B-SUPREME study. Additionally, we are encouraged by the progress of our HBV ASO program, which has shown promising preclinical results for oligonucleotide treatment of HBV infection.”

Preclinical Data

The preclinical posters showcased Aligos’ and its collaborators’ continued innovation and commitment to advancing next-generation therapies in the liver and viral spaces with presentations spanning novel approaches and mechanistic insights.

Details of the presentations are as follows:

Pevifoscorvir sodium: Potential first-/best-in-class small molecule CAM-E under investigation for chronic hepatitis B virus (HBV) infection

Presentation #: 0198
Type: Oral Presentation
Title: Oral Once -Daily 300 mg ALG-000184, a Novel Capsid Assembly Modulator Demonstrates potent suppression of HBV DNA in Treatment-Naive or Currently-not -treated Subjects with Chronic HBV
Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
Date/Time: November 9, 2025 at 5:00pm – 6:30pm ET
Session: Next-generation HBV Therapeutics: Emerging Therapies and Search for Functional Cure

Poster #: 1208
Type: Poster Presentation
Title: Sustained Reduction of HBV Antigen Levels During the 8-Week Follow-up Period in Treatment Naïve (TN) or Currently-Not-Treated (CNT) HBeAg-Positive Subjects with Chronic Hepatitis B Virus Infection After 96-Week 300 mg ALG-000184
Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Poster #: 1251
Type: Poster Presentation
Title: Capsid Assembly Modulator ALG-001075 Prevents cccDNA Formation and HBV DNA Integration In Vitro
Presenter: Jordi Verheyen
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Poster #: 1338
Type: Poster Presentation
Title: Capsid Assembly Modulator ALG-001075 Binds and Directly Targets HBeAg
Presenter: Jordi Verheyen
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Preclinical

Poster #: 1248
Type: Poster Presentation
Title: Differentiation of HBV capsid assembly modulators based on stabilization of core protein oligomerization and residence time
Presenter: Cheng Liu, PhD
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Poster #: 1330
Type: Poster Presentation
Title: CAM-E and CAM-A Compounds Differentially Affect Phosphorylated and Non-Phosphorylated Hepatitis B Core Protein In Vitro
Presenter: Rene Geissler, PhD, Abbott Diagnostics Division
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Poster #: 1155
Type: Poster Presentation
Title: Lead Optimization and Selection of a Potential Best-in-Class HBV ASO
Presenter: Jin Hong, PhD
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: Hepatitis B (“1118-1367”)

Poster #: 1103
Type: Poster Presentation
Title: Two Pre-clinical Short Interfering RNA Molecules Targeting Human HSD17beta13 for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis
Presenter: Jieun Song, PhD
Date/Time: November 7, 2025 at 8:00am – 5:00pm ET
Session: MASLD/MASH - Experimental: Basic ("1001-1117")

The presentations can be found on the Posters & Presentations section of the Aligos website (www.aligos.com) after the live event.

About Aligos

Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology 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 for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, obesity, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.

For more information, please visit www.aligos.com or follow us on LinkedIn or X.

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 November 6, 2025 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 Contact
Aligos Therapeutics, Inc.
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com

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FAQ

What were the Week 96 HBV DNA results for ALGS (ALGS) pevifoscorvir sodium Phase 1?

In Phase 1 monotherapy, 300 mg pevifoscorvir achieved HBV DNA LLOQ in 100% (10/10) HBeAg+ subjects at Week 96; HBeAg- subjects reached LLOQ by Week 24 and maintained suppression to Week 96.

Did ALGS report any viral breakthrough with pevifoscorvir sodium through 96 weeks?

No viral breakthrough was reported in any subject receiving pevifoscorvir sodium monotherapy for up to 96 weeks.

What post-treatment HBV DNA maintenance did Aligos (ALGS) report after switching to NA therapy?

After 96 weeks of pevifoscorvir then 8 weeks NA-only, 75% (6/8) HBeAg+ and 100% (8/8) HBeAg- subjects maintained HBV DNA

What preclinical evidence did Aligos (ALGS) present on ALG-001075 and cccDNA?

Preclinical in vitro data showed ALG-001075 can prevent cccDNA formation and HBV DNA integration.

When and where did Aligos (ALGS) present pevifoscorvir sodium data at The Liver Meeting 2025?

An oral presentation (Presentation #0198) occurred on Nov 9, 2025 at 5:00pm ET; multiple posters were presented Nov 7–9, 2025 in Washington, D.C.

How durable were antigen and RNA reductions after pevifoscorvir sodium treatment in ALGS data?

HBV antigen and HBV RNA reductions were maintained during the 8-week NA-only follow-up, suggesting persistent biomarker decline post-treatment.