Functional cure for HBV
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Aligos Therapeutics (NasdaqCM:ALGS) 2025 Conference Transcript
2025-11-17 16:02
Summary of Aligos Therapeutics Conference Call Company Overview - **Company**: Aligos Therapeutics (NasdaqCM:ALGS) - **Event**: Jefferies' London Healthcare Conference - **Date**: November 17, 2025 Key Points on Aligos Therapeutics and its Pipeline Lead Programs - **PEVY/PhosCovir**: Lead program targeting hepatitis B, previously known as ALG-000184 [2][3] - **ALG-009**: A beta thyroid agonist that has completed phase 2A testing, with potential applications in obesity and metabolic diseases [2][20] - **Pan-coronavirus protease inhibitor**: Currently undergoing a phase 2 study in the UK funded by the MRC [2] Hepatitis B Virus (HBV) Insights - **Prevalence**: Approximately 250 million patients globally, with significant populations in China (70 million), the US (2-2.5 million), and Western Europe (14 million) [3] - **Current Treatments**: Standard care includes nucleoside analogs and pegylated interferon, but these have limitations, including progression to end-stage liver disease and liver cancer [4][5] - **Unmet Medical Need**: A study indicated that 4% of patients on nucleoside therapy developed hepatocellular carcinoma over five years, highlighting the need for more effective treatments [4] Mechanism of Action for PEVY - **Capsid Assembly Modulators**: PEVY is designed to block both the replication of HBV and the establishment of cccDNA, which is crucial for the virus's persistence [8][9] - **Pharmacological Improvements**: Oral bioavailability of PEVY was increased from 5% to 80% through laboratory modifications [9] - **Clinical Results**: In early studies, PEVY demonstrated significant reductions in HBV DNA, outperforming standard nucleoside therapies [11][12] Clinical Trial Data - **Efficacy**: By week 48, 60% of E positive patients were below the limit of quantitation for HBV DNA, and 100% of E negative patients achieved similar results [12][13] - **Comparison with Standard Care**: PEVY showed a greater log reduction in HBV DNA compared to tenofovir, a standard nucleoside analog [11][13] - **Safety Profile**: No patients discontinued therapy due to adverse events, indicating a favorable safety profile [15] Future Directions - **Ongoing Studies**: A phase 2 clinical study comparing PEVY to TDF is underway, with an interim analysis expected early next year [17][19] - **Potential for Standard of Care**: PEVY is positioned to become the standard for chronic suppression of HBV, especially for patients not eligible for functional cure therapies [19] ALG-009 Developments - **Potency and Selectivity**: ALG-009 has shown to be significantly more potent than existing beta thyroid agonists, with a favorable pharmacokinetic profile [20][21] - **Phase 2b Readiness**: The drug is ready to enter phase 2b trials, with promising data on fat reduction in liver disease [21] Additional Insights - **Resistance Mechanism**: PEVY has shown no emergence of drug-resistant variants in clinical studies, which is a significant advantage over previous capsid assembly modulators [24][25] - **Regulatory Considerations**: The ability to conduct monotherapy with PEVY is crucial for FDA approval for chronic suppression, differentiating it from previous therapies that required combination treatments [25] This summary encapsulates the critical aspects of Aligos Therapeutics' conference call, focusing on their innovative approaches to treating hepatitis B and metabolic diseases, as well as the promising data from their clinical trials.
Arbutus Presents Clinical Trial Data from its Two HBV Assets, Imdusiran and AB-101, at the European Association for the Study of the Liver (EASL) Congress 2025
GlobeNewswire News Room· 2025-05-07 06:01
Core Insights - Arbutus Biopharma Corporation presented promising data on imdusiran and AB-101 at the EASL Congress 2025, indicating potential for functional cure in chronic hepatitis B patients [1][5] Group 1: Imdusiran and Clinical Trials - Imdusiran, when combined with VTP-300 and low-dose nivolumab, has shown to achieve functional cure in chronic hepatitis B (cHBV) patients [1] - In the Phase 2a clinical trial (IM-PROVE II), patients receiving imdusiran (60mg every 8 weeks) demonstrated significant reductions in HBsAg levels, with 25% of patients in the group receiving nivolumab achieving functional cure [2][7] - A total of 8 patients across all Phase 2a trials have been reported to achieve functional cure, with 7 of these having baseline HBsAg levels below 1000 IU/mL [3] Group 2: AB-101 and Safety Profile - AB-101, an oral PD-L1 inhibitor, has been shown to be generally safe and well-tolerated in a Phase 1a/1b clinical trial, with no liver dysfunction reported in cHBV patients [1][4] - Data from the first cohort of cHBV patients indicated that daily dosing of 10mg of AB-101 for 28 days was well tolerated, with no immune-related adverse events reported [4][10] Group 3: Background on Hepatitis B and Arbutus - Chronic hepatitis B infection represents a significant unmet medical need, affecting over 250 million people globally, with approximately 1.1 million deaths annually from related complications [11] - Arbutus Biopharma is focused on developing innovative therapies for infectious diseases, particularly chronic HBV infection, and is also involved in legal actions to protect its intellectual property [12]
Arbutus to Present Imdusiran and AB-101 Data at EASL Congress 2025
Newsfilter· 2025-04-23 06:01
Core Insights - Arbutus Biopharma Corporation announced the acceptance of five abstracts for presentation at the EASL Congress 2025, including one late-breaker, highlighting the company's ongoing research in hepatitis B treatments [2][9]. Group 1: Abstract Presentations - Five abstracts will be presented in the Viral Hepatitis B and D session on May 8, 2025, showcasing new therapies and strategies [3]. - The late-breaker abstract will focus on the antiviral efficacy and safety of imdusiran followed by VTP-300 in chronic hepatitis B subjects [9]. Group 2: Key Findings from Abstracts - Abstract 1768 discusses the factors associated with functional cure in chronic hepatitis B subjects, indicating that baseline HBsAg levels are significant [4]. - Abstract 2043 reveals that rapid HBV RNA decline during treatment with imdusiran and interferon is linked to HBsAg seroclearance [6]. - Abstract 1990 presents the pharmacokinetics and pharmacodynamics of AB-101, showing it to be safe and well-tolerated with dose-responsive increases in PD-L1 receptor occupancy [7]. - Abstract 1978 indicates that AB-101 is well-tolerated in both healthy and chronic hepatitis B subjects, with ongoing dosing studies [8]. Group 3: Product Information - Imdusiran is an RNAi therapeutic designed to reduce HBV viral proteins, showing promising results in Phase 2a trials for achieving functional cure rates [10]. - AB-101 is an oral PD-L1 inhibitor currently in Phase 1a/1b trials, aimed at reactivating exhausted HBV-specific T-cells [11]. Group 4: Industry Context - Chronic hepatitis B infection affects over 250 million people globally, representing a significant unmet medical need, with approximately 1.1 million deaths annually from related complications [12].