Aligos Therapeutics Presents Positive Data at APASL 2025
Aligos Therapeutics (ALGS) announced positive data from three presentations at APASL 2025, highlighting significant progress in their liver disease treatments. ALG-000184 demonstrated strong antiviral activity in chronic hepatitis B patients, with 100% of HBeAg+ subjects (9/9) and 91% of HBeAg- subjects achieving sustained HBV DNA suppression, with no viral resistance observed up to 96 weeks.
The company's ALG-055009 showed promising results in MASH patients, with doses of 0.5-0.9mg achieving placebo-adjusted median relative reductions in liver fat up to 46.2%. Up to 70% of subjects achieved ≥30% reduction in liver fat. Notably, 11/14 subjects on stable GLP-1 agonists treated with ALG-055009 showed liver fat decreases, while all 4 placebo subjects on GLP-1 agonists experienced increases.
Aligos Therapeutics (ALGS) ha annunciato dati positivi da tre presentazioni all'APASL 2025, evidenziando progressi significativi nei loro trattamenti per le malattie epatiche. ALG-000184 ha dimostrato una forte attività antivirale nei pazienti con epatite B cronica, con il 100% dei soggetti HBeAg+ (9/9) e il 91% dei soggetti HBeAg- che hanno raggiunto una soppressione sostenuta dell'HBV DNA, senza resistenza virale osservata fino a 96 settimane.
Il ALG-055009 dell'azienda ha mostrato risultati promettenti nei pazienti con MASH, con dosi di 0,5-0,9 mg che hanno raggiunto riduzioni relative medie in grasso epatico aggiustate rispetto al placebo fino al 46,2%. Fino al 70% dei soggetti ha ottenuto una riduzione ≥30% del grasso epatico. Notavelmente, 11/14 soggetti in trattamento stabile con agonisti del GLP-1 trattati con ALG-055009 hanno mostrato diminuzioni del grasso epatico, mentre tutti e 4 i soggetti del gruppo placebo in trattamento con agonisti del GLP-1 hanno registrato aumenti.
Aligos Therapeutics (ALGS) anunció datos positivos de tres presentaciones en APASL 2025, destacando avances significativos en sus tratamientos para enfermedades hepáticas. ALG-000184 demostró una fuerte actividad antiviral en pacientes con hepatitis B crónica, con el 100% de los sujetos HBeAg+ (9/9) y el 91% de los sujetos HBeAg- logrando supresión sostenida de HBV DNA, sin resistencia viral observada hasta 96 semanas.
El ALG-055009 de la compañía mostró resultados prometedores en pacientes con MASH, con dosis de 0.5-0.9 mg logrando reducciones relativas medianas en grasa hepática ajustadas al placebo de hasta el 46.2%. Hasta el 70% de los sujetos lograron una reducción ≥30% en grasa hepática. Notablemente, 11/14 sujetos en tratamiento estable con agonistas de GLP-1 tratados con ALG-055009 mostraron disminuciones en la grasa hepática, mientras que los 4 sujetos del grupo placebo en agonistas de GLP-1 experimentaron aumentos.
Aligos Therapeutics (ALGS)는 APASL 2025에서 세 가지 발표로 긍정적인 데이터를 발표하며 간 질환 치료에서 중요한 진전을 강조했습니다. ALG-000184는 만성 B형 간염 환자에서 강력한 항바이러스 활성을 보여주었으며, HBeAg+ 대상자(9/9)의 100%와 HBeAg- 대상자 중 91%가 지속적인 HBV DNA 억제를 달성하였고, 96주까지 바이러스 저항성이 관찰되지 않았습니다.
회사의 ALG-055009은 MASH 환자에서 유망한 결과를 보여주었으며, 0.5-0.9mg의 용량으로 플라시보 조정된 간 지방의 중간 상대 감소를 최대 46.2%까지 달성했습니다. 최대 70%의 대상자가 간 지방이 ≥30% 감소했습니다. 특히, ALG-055009으로 치료받은 GLP-1 작용제 안정적인 치료를 받은 11/14명의 대상자가 간 지방 감소를 보였고, GLP-1 작용제를 받은 플라시보 그룹의 4명은 모두 증가했습니다.
Aligos Therapeutics (ALGS) a annoncé des données positives lors de trois présentations à l'APASL 2025, mettant en lumière des progrès significatifs dans leurs traitements des maladies du foie. ALG-000184 a démontré une forte activité antivirale chez les patients atteints d'hépatite B chronique, avec 100 % des sujets HBeAg+ (9/9) et 91 % des sujets HBeAg- atteignant une suppression soutenue de l'ADN du VHB, sans résistance virale observée jusqu'à 96 semaines.
Le ALG-055009 de l'entreprise a montré des résultats prometteurs chez les patients atteints de MASH, avec des doses de 0,5 à 0,9 mg atteignant des réductions relatives médianes du gras hépatique ajustées au placebo allant jusqu'à 46,2 %. Jusqu'à 70 % des sujets ont obtenu une réduction ≥30 % du gras hépatique. Il est à noter que 11/14 sujets sous agonistes du GLP-1 traités avec ALG-055009 ont montré des diminutions du gras hépatique, tandis que les 4 sujets du groupe placebo sous agonistes du GLP-1 ont connu des augmentations.
Aligos Therapeutics (ALGS) gab positive Daten aus drei Präsentationen auf der APASL 2025 bekannt und hob bedeutende Fortschritte bei ihren Behandlungen von Lebererkrankungen hervor. ALG-000184 zeigte eine starke antivirale Aktivität bei Patienten mit chronischer Hepatitis B, wobei 100 % der HBeAg+ Probanden (9/9) und 91 % der HBeAg- Probanden eine nachhaltige HBV-DNA-Suppression erreichten, ohne dass bis zu 96 Wochen virale Resistenzen beobachtet wurden.
Das ALG-055009 des Unternehmens zeigte vielversprechende Ergebnisse bei MASH-Patienten, wobei Dosen von 0,5-0,9 mg placebo-adjustierte mediane relative Reduktionen des Leberfetts von bis zu 46,2 % erreichten. Bis zu 70 % der Probanden erzielten eine Reduktion von ≥30 % des Leberfetts. Bemerkenswert ist, dass 11/14 Probanden, die stabil mit GLP-1-Agonisten behandelt wurden, eine Abnahme des Leberfetts zeigten, während alle 4 Probanden der Placebo-Gruppe unter GLP-1-Agonisten eine Zunahme erfuhren.
- 100% HBV DNA suppression achieved in HBeAg+ subjects with ALG-000184
- 91% of HBeAg- subjects achieved HBV DNA below detection limit
- No viral resistance observed in ALG-000184 treatment up to 96 weeks
- ALG-055009 achieved up to 46.2% reduction in liver fat vs placebo
- 70% of subjects achieved ≥30% liver fat reduction with ALG-055009
- None.
Insights
Aligos Therapeutics has delivered positive clinical data across both of its key programs targeting major liver diseases. For ALG-000184 in hepatitis B, the 100% viral suppression rates in both HBeAg+ and HBeAg- patients (9/9 and 11/11 subjects respectively) with sustained efficacy through 84-96 weeks represent impressive antiviral potency. The multi-log reductions in viral markers (HBsAg, HBeAg, HBcrAg) and absence of viral resistance suggest a potentially differentiated profile compared to existing nucleos(t)ide analogs.
Particularly noteworthy is ALG-000184's dual mechanism as a Capsid Assembly Modulator with extended effects (CAM-E), which could position it as both a backbone therapy and contributor to functional cure regimens - addressing the holy grail in HBV treatment.
For ALG-055009 in MASH, meeting the primary endpoint with up to 46.2% placebo-adjusted relative reduction in liver fat and 70% of patients achieving ≥30% fat reduction (a threshold associated with histological improvement) demonstrates competitive efficacy in the emerging THR-β agonist class. The observed efficacy in patients already on GLP-1 therapy is especially significant, suggesting potential complementary effects that could preserve ALG-055009's market opportunity even as GLP-1 adoption increases.
Both compounds demonstrated favorable tolerability profiles, creating a strong risk-benefit proposition for these chronic disease markets. These results substantially de-risk Aligos's clinical pipeline and strengthen their competitive position in two substantial liver disease markets.
These dual positive readouts represent significant clinical validation for Aligos's pipeline. In HBV, ALG-000184's 100% viral suppression rate with no resistance through 96 weeks positions it favorably against established nucleos(t)ide analogs. The CAM-E mechanism with demonstrated impact on multiple viral markers suggests differentiation from other capsid inhibitors in development.
For the MASH program, ALG-055009's 46.2% placebo-adjusted fat reduction compares favorably with other THR-β agonists in development. The 70% responder rate for clinically meaningful ≥30% fat reduction strengthens the efficacy profile. Most strategically valuable is the efficacy demonstrated in patients already on GLP-1 therapy - creating a potential complementary treatment approach rather than competing directly with this rapidly expanding drug class.
With a microcap valuation of just
The company has not disclosed cash position in this release, so runway considerations remain an important factor to monitor. However, these positive data points should strengthen Aligos's position for potential partnering discussions or capital raising if needed to advance these programs through later-stage development.
SOUTH SAN FRANCISCO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- 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 positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China.
“We are pleased to present preliminary data out to 96 weeks in our Phase 1 study of ALG-000184, which continues to demonstrate first-/best-in-class reductions in important HBV markers,” stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. “Additionally, the HERALD data from the Phase 2a study of ALG-055009 in MASH subjects demonstrated robust reductions in liver fat, with a subgroup analysis in subjects on stable GLP-1 agonist therapy, showing a potential role for ALG-055009 in combination with other therapies.”
Two oral presentations will highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B virus (HBV) infection in both HBeAg-positive and HBeAg-negative subjects, demonstrating the potential for the molecule to become first-line therapy for chronic suppression and the backbone for regimens aimed at functional cure.
Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated HBV DNA suppression (<LLOQ <10 IU/mL) in 9/9 (
All subjects achieved HBV RNA < LLOQ by Week 52 in HBeAg+ subjects and Week 8 in HBeAg- subjects. Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects. These reductions demonstrate the activation of the CAM-E second mechanism. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough observed in subjects ≤96 weeks and no known CAM resistant mutations identified with monotherapy treatment.
Additionally, the third oral presentation will highlight the best-in-class potential of ALG-055009, a purpose built THR-β agonist discovered by Aligos scientists. 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
Details of the presentations are as follows:
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B (CHB)
Abstract #: 0094
Title: Monotherapy with the Capsid Assembly Modulator ALG-000184 Results in Rapid Viral Load Reduction and High Viral Suppression Rates in Untreated HBeAg-Negative Subjects with Chronic Hepatitis B Virus Infection
Presenter: Ed Gane, MBChB, MD, FRACP, FAASLD, MNZM, Professor of Medicine at the University of Auckland, New Zealand, Hepatologist and Deputy Director of the New Zealand Liver Unit at Auckland City Hospital
Date/Time: March 28, 2025, 3:30pm – 4:30pm GMT+8
Abstract #: 0394
Title: Monotherapy with the Capsid Assembly Modulator ALG-000184 Results in High Viral Suppression Rates in Untreated HBeAg-Positive Subjects with Chronic Hepatitis B Virus 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: March 29, 2025, 11:00am – 12:00pm GMT+8
ALG-055009: Potential best-in-class small molecule THR-β for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Abstract #: 0257
Title: ALG-055009, a Novel Thyroid Hormone Receptor Beta (THR-β) Agonist, was Well-tolerated with Significant Reductions in Liver Fat at Week 12 in Non-cirrhotic MASH Patients in the Randomized, Double-Blind, Placebo-controlled Phase 2a HERALD Study
Presenter: Stanley Wang, MD
Date/Time: March 29, 2025 at 2:30pm – 3:30pm GMT+8
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 infection, 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 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
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
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Inizio Evoke
Jake Robison
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Jake.Robison@inizioevoke.com
FAQ
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