Aligos Therapeutics Presents Positive Data at the EASL Congress 2025

/EIN News/ -- SOUTH SAN FRANCISCO, Calif., May 08, 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 at the European Association for the Study of the Liver (EASL) Congress 2025, being held May 7 – 10, 2025 in Amsterdam, Netherlands.

“We are pleased to have eight presentations at this year’s EASL Congress from programs across our pipeline,” stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. “In particular, we are excited to share an update on the 96-week data from the monotherapy cohort receiving 300 mg ALG-000184. All subjects in both the HBeAg⁺ and HBeAg^- cohorts have achieved HBV DNA viral suppression < LLOQ (10 IU/mL) and continue to demonstrate sustained log₁₀ reductions in viral antigens such as HBcrAg. These data further strengthen our belief that ALG-000184 is a first-/best-in-class asset with the potential to improve patient outcomes. Additionally, we will present biomarker and subgroup analyses from the Phase 2a HERALD study. These data continue to demonstrate the best-in-class potential of ALG-055009 across the cardio-metabolic space.”

Two presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B virus (HBV) infection in both untreated HBeAg⁺ and HBeAg^- subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure.

In HBeAg⁺ subjects with a very high mean HBV DNA level of 8.0 log₁₀ IU/mL at baseline, all experienced profound and persistent HBV DNA reductions after receiving an oral daily dose of 300 mg ALG-000184 monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, target detected or target not detected). With treatment extension, this rate increased to 9 of 9 subjects (100%) at Week 96. Additionally, HBV DNA level continuously declined to < LLOQ (target not detected, <4.29 IU/mL) in 5 of 9 subjects at Week 96.

In HBeAg^- subjects, all 11 (100%) had rapid decline in HBV DNA levels and achieved sustained HBV DNA suppression (HBV DNA < LLOQ, target detected or target not detected) by Week 24. The HBV DNA suppression level was maintained in the ALG-000184 monotherapy cohort for up to 96 weeks, with further decline in HBV DNA to < LLOQ, target not detected, observed in all subjects (8/8) at Week 96.

Importantly, no viral breakthrough was observed in any chronic HBV infection subjects receiving ALG-000184 monotherapy for up to 96 weeks. The resistant analysis reported no known CAM resistant mutations had been identified with ALG-000184 monotherapy.   

HBV RNA level achieved < LLOQ (10 copies/mL) in all HBeAg⁺ and HBeAg^- subjects by Week 52 and Week 8, respectively. 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 2^nd mechanism of action of ALG-000184.

A favorable tolerability profile has been demonstrated in untreated HBeAg⁺ and HBeAg^- subjects receiving 300 mg ALG-000184 for up to 96 weeks.

Additionally, two presentations will showcase the best-in-class potential of ALG-055009, a purpose built THR-β agonist discovered by Aligos scientists. As previously presented at AASLD’s The Liver Meeting in 2024, 12-weeks of once daily ALG-055009 treatment in MASH patients met the primary endpoint, with robust reductions in liver fat content at Week 12. Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at Week 12, with placebo-adjusted median relative reductions up to 46.2% as measured by MRI-PDFF. Eighteen subjects who were on stable GLP-1 agonist therapy qualified for enrollment in the study, with liver fat content meeting the inclusion criteria of ≥10% at baseline as measured by MRI-PDFF. Notably, 11/14 subjects on stable GLP-1 agonists treated with ALG-055009 had liver fat decreases, whereas 4/4 subjects on stable GLP-1 agonists treated with placebo had increases in liver fat over the 12-week dosing period. Treatment with ALG-055009 was well-tolerated, with rates of gastrointestinal-related AEs similar to placebo.

New data being presented at the EASL congress will demonstrate substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment. In addition, statistically significant improvements in atherogenic lipids were achieved with 12 weeks of ALG-055009 treatment. Reductions in lipids/lipoproteins were observed even in the context of stable GLP-1 agonist or statin use. This data suggests an added benefit of ALG-055009 for patients at risk for cardiovascular disease in addition to the previously reported liver fat lowering properties in a MASLD/MASH population.

Details of the presentations are as follows:

ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

Poster #: THU-261
Title: Monotherapy with the Novel Capsid Assembly Modulator ALG-000184 for up to 96 Weeks Results in Profound and Sustained HBV DNA Suppression in Untreated Subjects with Chronic HBV Infection
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: May 8, 2025 at 4:15pm – 5:00pm CET; May 8, 2025 at 8:30am – 5:00pm CET
Session: Poster Tour; Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

Poster #: THU-256
Title: The Safety and Antiviral Effect of Oral Daily 300 mg ALG-000184 in Combination with Entecavir for up to 96 Weeks in Untreated HBeAg-Positive Subjects with Chronic Hepatitis B Virus Infection
Presenter: Professor Jinlin Hou, MD, Chairman and Professor of the Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Date/Time: May 8, 2025 at 8:30am – 5:00pm CET
Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

Poster #: THU-242
Title: Viral kinetics and sequence analysis of a phase I monotherapy study in subjects with chronic hepatitis B reveals a high barrier of resistance to the capsid assembly modulator ALG-000184
Presenter: Andreas Jekle, PhD
Date/Time: May 8, 2025 at 8:30am – 5:00pm CET
Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies

ALG-055009: Potential best-in-class small molecule THR-β for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Poster #: SAT-451
Title: ALG-055009, a novel thyroid hormone receptor beta agonist, demonstrated significant reductions in atherogenic lipids/lipoproteins, including lipoprotein (a), in patients with presumed metabolic dysfunction-associated steatohepatitis in the Phase 2a HERALD
Presenter: Stanley Wang, MD, PhD
Date/Time: May 8, 2025 at 9:45am – 10:30am CET; May 10, 2025 at 8:30am – 4:00pm CET
Sessions: Poster tour; Poster - MASLD: Therapy

Poster #: SAT-450
Title: ALG-055009, a novel thyroid hormone receptor beta (THR-beta) agonist, demonstrated robust reductions in liver fat at Week 12 across subgroups including glucagon-like peptide-1 (GLP-1) receptor agonist users in non-cirrhotic MASH patients in the Phase 2a HERALD study
Presenter: Megan Fitzgerald, PhD
Date/Time: May 10, 2025 at 8:30am – 4:00pm CET
Session: Poster - MASLD: Therapy

Poster #: SAT-430
Title: Population pharmacokinetic/pharmacodynamic modelling of novel thyroid hormone receptor beta agonist ALG-055009 reveals statistically significant correlation between exposure and key efficacy endpoints
Presenter: Kha Le, PhD
Date/Time: May 10, 2025 at 8:30am – 4:00pm CET
Session: Poster - MASLD: Therapy

Poster #: FRI-450
Title: ALG-055009, a potent and selective thyroid hormone receptor beta agonist for the treatment of metabolic dysfunction-associated steatohepatitis, induces pro-metabolic and anti-fibrotic gene expression in the liver of diet-induced obese mice
Presenter: Xuan Luong, PhD
Date/Time: May 9, 2025 at 8:30am – 5:00pm CET
Session: Poster - MASLD: Experimental and pathophysiology

Preclinical

Poster #: FRI-257
Title: Next generation hepatitis B virus antisense oligonucleotides incorporating novel chemistries demonstrated significantly improved properties compared to current clinical candidates
Presenter: Jin Hong, PhD
Date/Time: May 9, 2025 at 8:30am – 5:00pm CET
Session: Poster - Viral Hepatitis: Experimental and pathophysiology

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 infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.

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

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