2023 European Liver Association: Aligos' Five Innovative hepatitis B Drugs Development Core Content and Prospects

Tech 2023-07-23 13:25:41 Source: Network

AligosTherapeutics in the clinical phase brought a total of five new research advances in innovative hepatitis B drugs at the 2023 European Liver Annual Conference (EASL2023), including two candidate drugs in the phase I clinical development phase, and progress in compounds in the pre clinical research phase. The following are the core contents of these 5 research developments and comments during the Aligos European Liver Conference

AligosTherapeutics in the clinical phase brought a total of five new research advances in innovative hepatitis B drugs at the 2023 European Liver Annual Conference (EASL2023), including two candidate drugs in the phase I clinical development phase, and progress in compounds in the pre clinical research phase. The following are the core contents of these 5 research developments and comments during the Aligos European Liver Conference.

Source Aligos

1. A research progress released during the current European Liver Congress, which was led by Professor Hou Jinlin of China, is a kind of shell assembly regulator ALG-000184. It has been used together with Entecavir (ETV) for 28 weeks, with good tolerance. In untreated hepatitis B e antigen positive patients, the level of hepatitis B B surface antigen (HBsAg) has significantly decreased.

ALG-000184 + ETVSource Aligos

2. The safety, pharmacokinetics (PK) and antiviral activity of a single incremental dose of ALG-125755 (a GalNAc binding small interfering RNA) in patients with chronic hepatitis B. This study was led by AlinaJucov, M.D.

This study concluded that a siRNA aimed at reducing HBsAg (HBsAg) in patients with chronic hepatitis B (CHB), through a single subcutaneous injection of 50mg and 120mg ALG-125755, led to a dose-dependent reduction of HBsAg levels within 90 days. Importantly, the safety and PK characteristics of these dose levels also support further evaluation of higher dose levels.

3. The pharmacodynamic persistence of a GalNAc bound siRNAALG-125755 is associated with total siRNA and RNA inducible complex (RISC) binding siRNA in mouse liver. This study was led by Professor KusumGupta.

This study concludes that in AAV-HBV mice, ALG-125755 has been shown to bind to argonaute-2 (AGO-2), confirming its mechanism of action consistent with siRNA. In addition, the pharmacological response of HBsAg reduction and persistence is associated with total siRNA and RISC binding siRNA in mouse liver.

4. The preclinical pharmacokinetics, pharmacodynamics and efficacy relationship of the liver targeting PD-L1 small molecule inhibitor ALG-093702 in different in vivo models, which was mainly taught by Dr. Tongfei Wu. Summary: ALG-093702 is a liver targeted PD-L1 small molecule inhibitor that exhibits similar efficacy in vitro to the PD-L1 antibody drug Durvalumab, as well as in vivo PD-L1 target occupancy and tumor growth inhibition. Preclinical pharmacokinetics, pharmacodynamics, and efficacy data provide guidance for effective human dose prediction and medication strategies in clinical studies of oral liver targeted PD-L1 small molecule inhibitors.

5. A potent human PD-L1siRNA leads to a significant reduction in AAV-HBV infected liver cells in human PD-1/PD-L1 knockout mice through the immune activation pathway, led by Dr. Jin Hong. Conclusion: ALG-072571 is a liver targeted PD-L1 siRNA therapy. In human PD-1/PD-L1 double knockout mice, the number of hepatocytes infected by AAV hepatitis B virus (HBV) was significantly reduced through immune activation. Therefore, ALG-072571 may lead to the restoration of immune response against HBV, thereby clearing HBV infection.

Dr. Lawrence Blatt, Chairman and CEO of Aligos, commented that we are pleased to present new clinical development data for our CHB candidate drug portfolio on EASL. These data highlight the progress we have made in promoting new Targeted therapy for a variety of liver diseases. We look forward to showcasing more data in our pipeline later this year.

Conclusion of Xiaofan Health: there are mainly three highlights in the research progress of innovative hepatitis B drugs brought by Aligos at this European Liver Congress. First, the Phase 1b clinical trial of oral coating assembly regulator (CAM-E) ALG-000184 is being evaluated, bringing promising research data; Second, the results of the ongoing phase I study to evaluate the single incremental dose of ALG-125755 (a GalNAc binding small interfering RNA) in chronic hepatitis B B virus suppression subjects; Thirdly, preclinical research on new compounds such as ALG-093702 and ALG-072571 is also being promoted.

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