Aligos Therapeutics Reports Promising 96-Week Data for HBV Treatment and Positive Results in MASH Study at APASL 2025
核心洞察
Aligos Therapeutics presented 96-week data showing ALG-000184 achieved significant HBV (搜索) DNA suppression in both HBeAg-positive and HBeAg-negative patients, positioning it as a potential first-line therapy for chronic hepatitis B.
The Phase 2a HERALD study of ALG-055009 demonstrated robust liver fat reduction in MASH (搜索) patients, with notable efficacy even in subjects already on GLP-1 (搜索) agonist therapy, suggesting potential combination treatment approaches.
Both investigational compounds maintained favorable safety profiles while showing best-in-class potential in their respective therapeutic areas, addressing significant unmet needs in liver disease treatment.
Aligos Therapeutics, Inc. (Nasdaq: ALGS) presented promising clinical data for two of its lead candidates at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025 in Beijing, China. The data showcased continued strong efficacy for the company's hepatitis B virus (搜索) (HBV (搜索)) treatment and metabolic dysfunction-associated steatohepatitis (搜索) (MASH (搜索)) therapy.
Strong 96-Week Data for HBV Capsid Assembly Modulator
Data from the Phase 1 study of ALG-000184, Aligos' small molecule capsid assembly modulator (搜索) (CAM-E (搜索)), demonstrated potent antiviral activity through 96 weeks of treatment in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients.
The 300 mg daily oral dose regimen showed rapid viral load reduction and high viral suppression rates in previously untreated patients. According to Professor Ed Gane from the University of Auckland, who presented data for HBeAg-negative subjects, ALG-000184 demonstrated "rapid viral load reduction and high viral suppression rates" in this patient population.
In a separate presentation, Professor Man-Fung Yuen from the University of Hong Kong reported similar efficacy in HBeAg-positive subjects, a group that has historically been more difficult to treat.
"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 (搜索) markers," stated Lawrence Blatt, PhD, MBA, Chairman, President, & CEO of Aligos Therapeutics.
The extended duration of viral suppression positions ALG-000184 as a potential first-line therapy for chronic HBV (搜索) suppression and as a backbone component in combination regimens aimed at achieving functional cure.
Promising Results for MASH Treatment
The company also presented data from its Phase 2a HERALD study of ALG-055009, a novel thyroid hormone receptor beta (搜索) (THR-β (搜索)) agonist being developed for MASH (搜索).
The randomized, double-blind, placebo-controlled study demonstrated that ALG-055009 was well-tolerated while achieving significant reductions in liver fat at week 12 in non-cirrhotic MASH (搜索) patients.
Notably, a subgroup analysis of patients on stable GLP-1 (搜索) agonist therapy showed that ALG-055009 provided additional benefit, suggesting potential synergistic effects when used in combination with other metabolic therapies.
"The HERALD data from the Phase 2a study of ALG-055009 in MASH (搜索) subjects demonstrated robust reductions in liver fat, with a subgroup analysis in subjects on stable GLP-1 (搜索) agonist therapy, showing a potential role for ALG-055009 in combination with other therapies," Dr. Blatt explained.
Clinical Implications and Market Potential
These positive results across two major liver disease programs highlight Aligos' progress in addressing significant unmet medical needs. Chronic hepatitis B affects approximately 296 million people globally, with current treatments rarely achieving functional cure. Meanwhile, MASH (搜索) prevalence continues to rise alongside obesity and diabetes epidemics, with limited approved treatment options.
The data presented at APASL 2025 positions Aligos as a potential leader in both therapeutic areas. ALG-000184's sustained viral suppression could transform chronic HBV (搜索) management, while ALG-055009's liver fat reduction efficacy, particularly in combination with GLP-1 (搜索) agonists, addresses the growing MASH (搜索) patient population.
About the Company
Aligos Therapeutics is a clinical-stage biotechnology company focused on developing novel therapeutics for liver and viral diseases. The company applies a science-driven approach to advance its purpose-built pipeline targeting high unmet medical needs including chronic hepatitis B, MASH (搜索), and coronaviruses.
The presentations from APASL 2025 are available on the company's website (www.aligos.com) in the Posters & Presentations section.