Aligos Therapeutics Presents Positive Data at The Liver Meeting (TLM) 2024
Aligos Therapeutics (ALGS) presented positive data at The Liver Meeting 2024, highlighting two key developments: First, ALG-000184 showed sustained antiviral activity in chronic hepatitis B patients, with 100% of HBeAg-positive subjects achieving HBV DNA suppression at 84 weeks, and 91% of HBeAg-negative subjects reaching below detection limits at 48 weeks. Second, their THR-β agonist ALG-055009 demonstrated significant liver fat reduction in MASH patients, with up to 46.2% placebo-adjusted median reductions at 12 weeks. Notably, 70% of subjects achieved ≥30% liver fat reduction, and the drug showed effectiveness in patients on GLP-1 agonists. Both compounds were well-tolerated with no significant safety concerns.
Aligos Therapeutics (ALGS) ha presentato dati positivi al Liver Meeting 2024, evidenziando due sviluppi chiave: innanzitutto, l'ALG-000184 ha mostrato un'attività antivirale sostenuta in pazienti con epatite B cronica, con il 100% dei soggetti HBeAg-positivi che ha raggiunto la soppressione dell'HBV DNA a 84 settimane, e il 91% dei soggetti HBeAg-negativi che ha superato i limiti di rilevabilità a 48 settimane. In secondo luogo, il loro agonista THR-β ALG-055009 ha dimostrato una significativa riduzione del grasso epatico nei pazienti affetti da MASH, con riduzioni medie aggiustate per placebo fino al 46,2% a 12 settimane. In particolare, il 70% dei soggetti ha ottenuto una riduzione del grasso epatico ≥30%, e il farmaco ha dimostrato efficacia in pazienti in trattamento con agonisti GLP-1. Entrambi i composti sono stati ben tollerati, senza preoccupazioni significative per la sicurezza.
Aligos Therapeutics (ALGS) presentó datos positivos en The Liver Meeting 2024, destacando dos desarrollos clave: primero, el ALG-000184 mostró una actividad antiviral sostenida en pacientes con hepatitis B crónica, con el 100% de los sujetos HBeAg-positivos logrando la supresión del ADN del VHB a las 84 semanas, y el 91% de los sujetos HBeAg-negativos alcanzando niveles por debajo de los límites de detección a las 48 semanas. Segundo, su agonista THR-β ALG-055009 demostró una reducción significativa de la grasa hepática en pacientes con MASH, con reducciones medianas ajustadas al placebo de hasta el 46,2% a las 12 semanas. Notablemente, el 70% de los sujetos logró una reducción de grasa hepática ≥30%, y el medicamento demostró eficacia en pacientes que recibían agonistas GLP-1. Ambos compuestos fueron bien tolerados sin preocupaciones significativas de seguridad.
알리고스 테라퓨틱스 (ALGS)는 2024년 간염 회의에서 긍정적인 데이터를 발표하며 두 가지 주요 개발 사항을 강조했습니다. 첫째, ALG-000184는 만성 B형 간염 환자에서 지속적인 항바이러스 활성을 보여주었으며, HBeAg 양성 주체 중 100%가 84주차에 HBV DNA 억제를 달성했으며, HBeAg 음성 주체 중 91%가 48주차에 검출 한계 이하에 도달했습니다. 둘째, THR-β 활성제인 ALG-055009는 MASH 환자에서 간 지방 감소를 상당히 나타냈으며, 12주차에 위약 조정 중위수에서 최대 46.2%의 감소를 기록했습니다. 특히, 70%의 주체가 ≥30%의 간 지방 감소를 달성했으며, 이 약물은 GLP-1 활성제를 복용하는 환자에서도 효과를 보였습니다. 두 화합물 모두 안전성에 대한 우려 없이 잘 견뎌졌습니다.
Aligos Therapeutics (ALGS) a présenté des données positives lors du Liver Meeting 2024, soulignant deux développements clés : tout d'abord, l'ALG-000184 a montré une activité antivirale soutenue chez des patients atteints d'hépatite B chronique, avec 100 % des sujets HBeAg-positifs atteignant une suppression de l'ADN du VHB à 84 semaines, et 91 % des sujets HBeAg-négatifs se situant en dessous des limites de détection à 48 semaines. Deuxièmement, leur agoniste THR-β, l'ALG-055009, a démontré une réduction significative de la graisse hépatique chez les patients atteints de MASH, avec des réductions médianes ajustées au placebo allant jusqu'à 46,2 % à 12 semaines. Notamment, 70 % des sujets ont obtenu une réduction de graisse hépatique ≥30 %, et le médicament s'est montré efficace chez les patients traités par des agonistes GLP-1. Les deux composés ont été bien tolérés sans préoccupations significatives en matière de sécurité.
Aligos Therapeutics (ALGS) präsentierte positive Daten auf dem Liver Meeting 2024 und hob zwei wichtige Entwicklungen hervor: Erstens zeigte ALG-000184 eine nachhaltige antivirale Wirkung bei Patienten mit chronischer Hepatitis B, wobei 100 % der HBeAg-positiven Probanden in 84 Wochen eine HBV-DNA-Suppression erreichten und 91 % der HBeAg-negativen Probanden in 48 Wochen unter der Nachweisgrenze blieben. Zweitens zeigte ihr THR-β-Agonist ALG-055009 eine signifikante Reduktion des Leberfettes bei MASH-Patienten, mit bis zu 46,2 % medianen Reduktionen im Vergleich zur Placebogruppe nach 12 Wochen. Bemerkenswerterweise erreichten 70 % der Probanden eine ≥30%ige Reduktion des Leberfettes, und das Medikament zeigte auch Wirksamkeit bei Patienten, die GLP-1-Agonisten erhielten. Beide Verbindungen wurden gut vertragen und es gab keine signifikanten Sicherheitsbedenken.
- ALG-000184 achieved 100% HBV DNA suppression in HBeAg-positive subjects at 84 weeks
- 91% of HBeAg-negative subjects reached below detection limits at 48 weeks
- ALG-055009 showed up to 46.2% liver fat reduction in MASH patients
- 70% of subjects achieved ≥30% liver fat reduction with ALG-055009
- Both compounds demonstrated favorable safety profiles
- None.
Insights
The clinical data for ALG-000184 and ALG-055009 demonstrates significant therapeutic potential in two major liver disease markets. For ALG-000184 in chronic hepatitis B, the 100% viral suppression rate in both HBeAg+ and HBeAg- patients, with no resistance development through 84 weeks, positions it strongly as a potential first-line therapy. The durability of response and clean safety profile are particularly noteworthy.
For ALG-055009 in MASH, achieving up to
These results suggest strong commercial potential in both indications, though market size and competition differ substantially between HBV and MASH therapeutic landscapes.
SOUTH SAN FRANCISCO, Calif., Nov. 19, 2024 (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 one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024, being held November 15 – 19, 2024 in San Diego, CA.
The clinical poster presentation highlighted the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) virus 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 sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 7/7 (
All subjects achieved sustained HBV RNA < LLOQ by Week 44 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. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment.
Additionally, the late-breaker oral presentation highlighted 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
Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) and apolipoprotein B and dose-dependent increases in SHBG were observed. In particular, ALG-055009 demonstrated a dose-dependent reduction from baseline of up to
“The presentation of longer duration dosing of ALG-000184 in CHB patients strengthens our belief that this therapy will become both first-line for chronic suppression as well as the backbone of next generation HBV treatments aimed at functional cure,” stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics. “Additionally, we are pleased to have presented the HERALD data, showing robust reductions in liver fat for patients treated with ALG-055009. The subgroup analysis in patients enrolled in the study on stable GLP-1 agonist therapy suggests a role for ALG-055009 to augment liver fat reductions in patients receiving incretin therapy.”
Details of the presentations are as follows:
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B (CHB)
Abstract #: 1213
Title: Monotherapy with the Capsid Assembly Modulator, ALG-000184, Results in High Viral Suppression Rates in Untreated HBeAg+ and HBeAg- 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: November 15, 2024, 8:00am – 5:00pm PT
Abstract #: 1266
Title: Capsid Assembly Modulators Such as ALG-001075 Induce Profound HBV DNA Knockdown and Directly Target HBeAg In Vitro
Presenter: Cheng Liu, PhD
Date/Time: November 15, 2024, 8:00am – 5:00pm PT
ALG-055009: Potential best-in-class small molecule THR-β for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Format: Oral presentation
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 Ongoing Randomized, Double-Blind, Placebo-controlled Phase 2
Presenter: Rohit Loomba, MD, MHSc, Chief, Division of Gastroenterology and Hepatology, University of California, San Diego
Date/Time: November 19, 2024 at 10:30am – 10:40am PT
Abstract #: 3226
Title: Nonclinical Toxicology Profile of ALG-055009, a Novel and Potent Thyroid Hormone Receptor β Agonist, for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Presenter: Dinah Misner, PhD
Date/Time: November 17, 2024, 8:00am – 5:00pm PT
The presentations can be found on the Posters & Presentations section of the Aligos website (www.aligos.com).
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 for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B 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, 2024 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.
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FAQ
What were the key results for ALG-000184 in chronic hepatitis B patients?
How effective was Aligos' ALG-055009 in reducing liver fat content?
Did ALGS's ALG-055009 show effectiveness in patients taking GLP-1 agonists?
