Aligos Therapeutics, Inc. · NASDAQ:ALGS

Aligos Therapeutics — APASL 2023

14 slides from Aligos Therapeutics's conference presentation, Feb 1, 2023

  1. Slide 1: ALG-000184 Dosed for 28 Days Well Tolerated, Rapidly Reduced Viral Markers in Chronic Hepatitis B

    The Capsid Assembly Modulator ALG-000184 Dosed for 28 Days Was Well Tolerated and Rapidly Reduced Viral Markers in Subjects with Chronic Hepatitis B, Including HBsAg in a Subset of HBeAg Positive Subjects with Elevated Baseline ALT Ed Gane1, MF Yuen2, Kosh Agarwal3, Alina Jucov4, Jinlin Hou5, Junqi

  2. Slide 2: Disclosures

    Disclosures • Member of Scientific Advisory Board for AbbVie, Abbott Diagnostics, Aligos, Arbutus, Arrowhead, Assembly, Avalia, Clear B Therapeutics, Dicerna, Enanta, Gilead Sciences, GlaxoSmithKline, Intellia, Janssen, Merck, Novartis, Genentech-Roche, Vaccitech, VIR Bio and Virion Therapeutics. •

  3. Slide 3: Background

    Background • Long-term treatment with nucleos(t)ide analogues (NAs) improves outcomes in chronic hepatitis B (CHB), but rarely results in functional cure1,2 • ALG-000184, a prodrug of ALG-001075, is a pan-genotypic capsid assembly modulator – empty (CAM-E) with the potential to enhance functional cu

  4. Slide 4: ALG-000184-201 Study Design

    ALG-000184-201 Study Design Treatment period Follow-up Wk 0 1 2 3 4 12 // (a) HBeAg negative 10 mg ALG-000184/Placebo No treatment 50 mg ALG-000184/Placebo No treatment 100 mg ALG-000184/Placebo No treatment Each cohort N=10 (8:2) (b) HBeAg positive 10 mg ALG-000184/Placebo No treatment 100 mg ALG-0

  5. Slide 5: ALG-000184-201 Baseline Characteristics

    ALG-000184-201 Baseline Characteristics HBeAg Negative HBeAg Positive Dose level 10 mg 50 mg 100 mg 10 mg 100 mg 300 mg ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG000184/PBO N N=9* N=10 N=10 N=8* N=10 N=12** Age, years, mean (SEM) 45.4 (1.8) 42.7 (2.8) 44.7 (2.9) 3

  6. Slide 6: Change in HBV DNA and HBV RNA

    ALG-000184-201 Change in HBV DNA and HBV RNA (i) Mean (SEM) Serum HBV DNA Levels Change (ii) Mean (SEM) Serum HBV RNA Levels Change from Baseline Through the End of Study from Baseline Through the End of Study % <LLOQ % <LLOQ • HBV DNA Roche Cobas® assay: Sonic laboratory: Lower Limit of Quantificat

  7. Slide 7: Antiviral Activity: HBV DNA

    ALG-000184-201 Antiviral Activity: HBV DNA HBeAg Negative HBeAg Positive Placebo Dose level 10 mg 50 mg 100 mg 10 mg 100 mg 300 mg Overall ALG-000184 ALG-000184 ALG-000184 ALG-000184 ALG-000184 ALG000184 N N=7 N=8 N=8 N=7 N=8 N=10 N=11 Baseline 4.1 4.8 4.2 8.5 8.3 8.4 5.8 mean (SEM) (0.1) (0.4) (0.4

  8. Slide 8: Antiviral Activity: HBV RNA

    ALG-000184-201 Antiviral Activity: HBV RNA HBeAg Negative HBeAg Positive Placebo Dose level 10 mg 50 mg 100 mg 10 mg 100 mg 300 mg Overall ALG-000184 ALG-000184 ALG-000184 ALG-000184 ALG-000184 ALG000184 N N=7 N=8 N=8 N=7 N=8 N=10 N=11 Baseline 1.2 2.1 1.7 8.5 7.8 7.4 4.3 mean (SEM) (0.4) (0.4) (0.4

  9. Slide 9: Individual Profiles for HBeAg Positive Subjects with Changes in HBsAg

    ALG-000184-201 Individual Profiles for HBeAg Positive Subjects with Changes in HBsAg Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 ALT Nucleoside Analog Nucleoside Analog HBV DNA HBsAg Time (days) • 4/8 subjects (#2-5) in 300 mg cohort had HBsAg reductions of up to 0.78 log10 IU/mL • 1 subject i

  10. Slide 10: HBsAg, DNA, & ALT in HBeAg+ Subjects Receiving ALG-000184

    ALG-000184-201 HBsAg, DNA, & ALT in HBeAg+ Subjects Receiving 100 or 300 mg ALG-000184 HBV DNA Change From Baseline at Day 28 Max HBsAg Change From Baseline Subject # Baseline ALT (log10 IU/mL) (log10 IU/mL) 1* Elevated -3.5 -0.5 2 Elevated -4.4 -0.2 3 Elevated -4.4 -0.35 4 Elevated -3.3 -0.8 5 Elev

  11. Slide 11: Safety

    ALG-000184-201 Safety HBeAg negative HBeAg positive Dose level 10 mg 50 mg 100 mg 10 mg 100 mg 300 mg ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO ALG-000184/PBO N subject with N=9 N=10 N=10 N=8 N=10 N=12 TEAE (Total) 2 (22) 6 (60) 6 (60) 0 10 (100) 10 (83.3) TEAE (Rela

  12. Slide 12: Pharmacokinetics of ALG-001075

    ALG-000184-201 Pharmacokinetics of ALG-001075 PK profile: dose proportional with low variability Patients who had reduction in HBsAg levels generally had higher steady state plasma ALG-001075 11

  13. Slide 13: Conclusions

    ALG-000184-201 Conclusions • Oral daily dosing with 10-300 mg of ALG-000184 for 28 days – Was well tolerated – Resulted in substantial declines in HBV DNA and RNA at all doses, regardless of HBeAg status – Resulted in HBsAg declines up to 0.8 log10 IU/mL at 100 mg and 300 mg dose. The 5 HBeAg-positi

  14. Slide 14: Acknowledgments

    ALG-000184-201 Acknowledgments The authors wish to thank the following for their contributions: • The subjects and their families for their participation • The clinical investigational study teams: 1. New Zealand Clinical Research, New Zealand 2. University of Hong Kong, Hong Kong 3. Institute of Li

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