Aligos Therapeutics, Inc. · NASDAQ:ALGS
Aligos Therapeutics — Technical Presentation (February 2023)
13 slides from Aligos Therapeutics's technical presentation, Feb 1, 2023
Slide 1: ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir
ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir Compared to Entecavir in HBeAg Positive Subjects with Chronic Hepatitis B infection Jinlin Hou1, Yanhua Ding1, Junqi Niu2, Liang Xie’er3 Benedetta Massetto4, Kha Le4, Tse-I Lin5, Matthew M
Slide 2: Disclosures
Disclosures • Advisory Board Member of AbbVie, Arbutus, Bristol Myers Squibb, Gilead Sciences, Johnson & Johnson, • Research grant from Bristol Myers Squibb and Johnson & Johnson 1
Slide 3: ALG-000184 Background
ALG-000184 Background • Capsid assembly modulators which produce empty viral particles (CAM-E) have been extensively studied for treating Chronic Hepatitis B (CHB) • CAM-E drugs have 2 antiviral mechanisms of action: – Inhibition of capsid assembly leading to reductions in HBV DNA and RNA levels – P
Slide 4: ALG-000184-201 Part 4 Study Design
ALG-000184-201 Part 4 Study Design Randomize N=8 3 active:1 placebo Follow-up (+ ETV) ALG-000184 100 mg + ETV x 24 weeks x 8 weeks Cohort 1 N=2 ALG-000184 + ETV Placebo + ETV Follow-up (+ ETV) N=11 x 12 weeks x 12 weeks x 8 weeks Randomize N=8 3 active:1 placebo Follow-up (+ ETV) ALG-000184 300 mg +
Slide 5: ALG-000184-201 Part 4 Key Study Entry Criteria
ALG-000184-201 Part 4 Key Study Entry Criteria Cohort 1 (Chronic HBV infection) – Treatment naïve – ALT and AST ≤1.2 × ULN – HBV DNA >107 IU/mL Cohort 2 (Chronic hepatitis B) – Treatment naïve or currently not treated – ALT and AST ≤5 × ULN – HBV DNA >2000 IU/mL Both Cohorts – HBeAg positive – HBsAg
Slide 6: ALG-000184-201 Baseline Characteristics
ALG-000184-201 Baseline Characteristics Cohort 1 Cohort 2 (100 mg ALG-000184 + ETV and (300 mg ALG-000184 + ETV and Placebo + ETV) Placebo + ETV) N N=11 N=11 Age, years, mean (SEM) 35.1 (2.1) 31.4 (3.3) Female, N (%) 7 (64) 6 (55) Asian, N (%) 11 (100) 11 (100) BMI, kg/m2, mean (SEM) 22.1 (0.8) 21.7
Slide 7: Safety
ALG-000184-201 Safety Cohort 1 Cohort 2 100 mg ALG-000184 + ETV 300 mg ALG-000184 + ETV Placebo + ETV Placebo + ETV N N=11 N=11 Serious Adverse Event (SAE) 0 0 Treatment Emergent Adverse Event (TEAE) 0 0 leading to study drug discontinuation Grade ≥3 TEAE 0 0 Grade 1 5 4 ALT elevation Grade 2 1 1 Co
Slide 8: Pharmacokinetics Plasma ALG-001075 Levels
Pharmacokinetics Plasma ALG-001075 Levels AUC0-24 Cohort N Cmax (ng/mL) (ng.hr/mL) 100 mg ALG-000184 + ETV 8 12,400 (15.5) 1,590 (21.4) 300 mg ALG-000184 + ETV 6 37,700 (25.7) 4,320 (31.5) Geometric mean (Geometric CV) • Plasma exposures at Day 1 increased dose proportionally with a low coefficient
Slide 9: Antiviral Activity Change in HBV DNA and RNA Over Time
Antiviral Activity Change in HBV DNA and RNA Over Time HBV DNA HBV RNA Reduction at Week 10 Placebo + ETV ALG-000184 100 mg + ETV ALG-000184 300 mg + ETV N=3 N=7 N=6 HBV DNA, mean (SEM) log10 IU/mL -3.7 (0.43) -4.9 (0.28) -5.2 (0.3) HBV RNA, mean (SEM) log10 copies/mL 0.08 (0.05) -2.7 (0.21) -3.3 (0
Slide 10: Change in HBsAg For Subjects Dosed At Least 10 Weeks
Cohorts 1 and 2 (100 and 300 mg ALG-000184 + ETV) Change in HBsAg For Subjects Dosed At Least 10 Weeks Clear downward trend for HBsAg among majority of 300 mg ALG-000184 treated subjects Effect more apparent with dosing beyond 4 weeks 9
Slide 11: Change in ALT For Subjects Dosed At Least 10 Weeks
Cohorts 1 and 2 (100 and 300 mg ALG-000184 + ETV) Change in ALT For Subjects Dosed At Least 10 Weeks Subjects with normal baseline ALT levels who had a >0.2 log10 reduction in HBsAg experienced mild and persistent elevations in ALT while receiving ALG-000184 and ETV, regardless of dose. Conversely,
Slide 12: ALG-000184-201 Conclusions
ALG-000184-201 Conclusions ALG-000184 combined with ETV in untreated HBeAg+ subjects with chronic HBV infection or CHB • Demonstrated a favorable safety and PK profile • Resulted in superior antiviral activity (HBV DNA and RNA) compared to ETV alone • Resulted in superior reductions in HBsAg (especi
Slide 13: ALG-000184-201 Acknowledgments
ALG-000184-201 Acknowledgments The authors wish to thank the following for their contributions: • The subjects and their families for their participation • The two clinical investigational study teams – Nanfang Medical University Nanfang Hospital Infection Disease Department – Jilin University the 1
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