Aligos Therapeutics (NasdaqCM:ALGS) Conference Transcript

Summary of Aligos Therapeutics Conference Call Company Overview - Company: Aligos Therapeutics (NasdaqCM:ALGS) - Focus: Development of therapies for liver and viral diseases, specifically targeting chronic hepatitis B virus (HBV) and metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Key Points on Chronic Hepatitis B Virus (HBV) - Prevalence: HBV is the largest chronic viral infection globally, affecting approximately three times more people than HIV [3] - Current Treatments: Standard care involves nucleoside and nucleotide analogs, which block virus replication but do not eliminate the long-lived cccDNA form of the virus [3][4] - Clinical Outcomes: A study in Taiwan showed that after five years of treatment with nucleoside analogs, 4% of patients developed liver cancer, and 5% experienced liver decompensation [4] - Need for Better Therapies: Deep and rapid suppression of HBV is essential to prevent liver disease and cancer, highlighting the limitations of current therapies [5] PEVI/PHOSCOVIR Development - Lead Program: PEVI is a next-generation capsid assembly modulator designed to treat chronic HBV [2] - Mechanism of Action: PEVI blocks the encapsulation of pre-genomic RNA and reduces cccDNA levels, which is a significant advancement over first-generation capsid assembly modulators [10][11] - Clinical Data: In a 96-week study, 100% of E antigen negative patients achieved HBV DNA levels below 10 international units, compared to only 20% in traditional treatments [16][22] - Resistance: PEVI has shown effectiveness against resistant variants of HBV, which is a significant advantage over previous treatments that led to drug resistance [17][18] B Supreme Phase II Study - Study Design: The B Supreme study will compare PEVI with nucleoside analogs in both E positive and E negative patient populations, focusing on achieving HBV DNA levels below 10 [21][22] - Endpoints: The study will measure antigen reductions and cccDNA levels, with paired biopsies to assess integration events related to HBV lifecycle [24][26] - Regulatory Approval: The study has received approval from regulatory agencies in 14 countries, indicating broad acceptance of its design [19][24] Future Milestones and Commercial Opportunity - Upcoming Data: Key data from the B Supreme study will be presented at the AASLD meeting, including post-treatment effects and interim analyses [46][47] - Market Opportunity: With 94% of HBV patients needing better chronic suppressive therapy, PEVI is positioned to become the standard of care, potentially increasing the rate of functional cures in combination therapies [39][42][44] MASH and ALG-055009 Development - Overview: ALG-055009 is a thyroid hormone receptor beta agonist aimed at treating MASH, showing improved potency and reduced side effects compared to existing therapies [50][52] - Clinical Results: In Phase IIa studies, ALG-055009 demonstrated a 46% reduction in liver fat, outperforming similar drugs [54] - Partnership Discussions: Aligos is in discussions with potential partners for ALG-055009, aiming to leverage its capabilities in cardiometabolic diseases [56] Conclusion - Aligos Therapeutics is advancing innovative therapies for HBV and MASH, with promising clinical data and a clear regulatory pathway for its lead programs. The company is well-positioned to address significant unmet needs in these areas, with a focus on improving patient outcomes and reducing healthcare costs associated with liver diseases [57][58]