Aligos Therapeutics Shares Positive Data at EASL 2024

Aligos Therapeutics Inc., a biopharmaceutical company specializing in innovative treatments for liver and viral diseases, has unveiled encouraging results from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy. The findings spotlight the robust antiviral capabilities of ALG-000184, an investigational drug for chronic hepatitis B (CHB), and explore other promising therapeutic approaches.

The clinical data emphasize ALG-000184’s efficacy in both HBeAg-positive and HBeAg-negative subjects. For HBeAg-positive CHB patients, data collected over a span of up to 72 weeks with a daily oral dose of 300 mg of ALG-000184 indicated sustained suppression of HBV DNA. An impressive 90% of subjects achieved undetectable levels of HBV DNA, with no instances of viral resurgence. Furthermore, the reduction in HBeAg levels to near-zero correlated with a positive trend in anti-HBe antibody (HBeAb) levels.

For HBeAg-negative CHB subjects, the reported data is equally promising. Over a treatment duration of up to 60 weeks with the same 300 mg daily dose, all 11 subjects exhibited complete suppression of HBV DNA and RNA, with levels dropping below the lower limit of quantification. Additionally, reductions in HBcrAg levels were observed, suggesting an inhibition of both HBV replication and the establishment or replenishment of cccDNA. Remarkably, ALG-000184 was well tolerated in both patient groups, and no viral breakthroughs were documented.

Lawrence Blatt, PhD, MBA, Chairman, President, and CEO of Aligos Therapeutics, commented on the significance of these findings. He emphasized ALG-000184’s potential as a highly potent antiviral agent for hepatitis B patients, irrespective of their HBeAg status. Blatt noted that the extent of HBV DNA suppression achieved with ALG-000184 surpasses that of current standard-of-care nucleos(t)ide therapies, potentially positioning ALG-000184 as a leading molecule in its class.

Beyond ALG-000184, Aligos presented other notable preclinical data. This included the potential of next-generation small interfering RNAs (siRNAs) in treating metabolic dysfunction-associated steatohepatitis (MASH) and CHB, as well as a novel CAM-A molecule for CHB treatment. These studies underscore Aligos' commitment to advancing therapeutic options across liver and viral diseases.

Detailed presentation highlights from the congress include:

- ALG-000184's potency in HBeAg-positive CHB subjects, showcasing extended treatment outcomes and reductions in viral markers. Professor Man-Fung Yuen from the University of Hong Kong presented these findings.

- Effects of ALG-000184 in untreated HBeAg-negative CHB subjects, demonstrating potent antiviral effects, including HBV DNA/RNA suppression and HBcrAg level declines. This presentation was delivered by Kosh Agarwal from King’s College Hospital NHS Foundation Trust.

- Associations of baseline characteristics with HBsAg responses in HBeAg-positive CHB subjects undergoing ALG-000184 treatment, presented by Kha Le, PhD.

Preclinical insights featured:

- Human PNPLA3-targeting siRNA molecules for MASH treatment, presented by Jieun Song, PhD.

- Second-generation HBV siRNAs with improved profiles compared to previous iterations, presented by Jin Hong, PhD.

- Non-HAP CAM-A molecules ALG-006746 and ALG-006780, which showed promising HBsAg reductions in AAV-HBV mice and favorable pharmacokinetic profiles, presented by Yannick Debing, PhD.

These presentations reflect Aligos' strategic focus on pioneering treatments for liver and viral diseases, leveraging their team's extensive expertise in drug development. Founded in 2018, Aligos aims to become a global leader in the field, addressing critical unmet medical needs with innovative therapeutics.

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