Aligos Therapeutics, Inc. · NASDAQ:ALGS
Aligos Therapeutics — APASL 2023
13 slides from Aligos Therapeutics's conference presentation, March 2023
Slide 1: The THR-Beta Agonist ALG-055009 Has a Favorable Safety and PK Profile in a Phase 1 Study
The THR-Beta Agonist ALG-055009 Has a Favorable Safety and Pharmacokinetic Profile and Dose Proportionally Lowers Lipid Biomarkers in a Phase 1 Study Matthew McClure [1], Hakim Charfi [2], Jean-Louis Pinquier [2], Benedetta Massetto [1]; Kha Le [1]; Ifong Kan-Eng [1]; Kusum Gupta [1]; Lawrence Blatt
Slide 2: Disclosures
Disclosures Personal I am an employee of Aligos Therapeutics Corporate This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including
Slide 3: Background
Background • Thyroid hormone receptor-beta (THR-β) is the primary THR expressed in liver and plays an important role in lipid metabolism1,2 • Therapeutics targeting THR-β represent a promising approach to treating patients with fatty liver by decreasing hepatic fat content and improving liver histol
Slide 4: Study Design: Typical SAD, MAD Design
Study Design Typical SAD, MAD Design Part 1: Single Ascending Dose (SAD) Part 2: Multiple Ascending Dose (MAD) – Dosing PO QD X 14 days N = up to 64 Healthy Volunteers N = up to 80 Subjects with Hyperlipidemia (LDL-C>110 mg/dL) n = 8 per Cohort, n = 6 ALG-055009 and n = 2 Placebo n = 10 per Cohort,
Slide 5: Demographics Balanced, Typical for HVs, Hyperlipidemia Patients
Demographics Balanced, Typical for HVs, Hyperlipidemia Patients SAD MAD ALG-055009 Dose Placebo 0.1 mg 0.3 mg 0.9 mg 2.6 mg 4 mg Placebo 0.3 mg 0.5 mg 0.6 mg 1 mg N N=10 N=6 N=6 N=6 N=6 N=6 N=8 N=8 N=8 N=8 N=8 41.3 39.1 41.4 33.4 Age (years) 42.2 (3.3) 41.7 (2.7) 35.7 (4.7) 30.7 (4.5) 35.2 (5.5) 38.
Slide 6: Safety: No Safety Findings
Safety No Safety Findings • No serious adverse events (SAEs), treatment emergent adverse events (TEAEs) leading to discontinuation, or Grade ≥3 TEAEs • No clinical evidence of hyper- or hypo-thyroidism • Most common (≥2 subjects reported) TEAEs SAD Dose (mg) MAD Dose (mg) TEAE Term Placebo 0.1 0.3 ≥
Slide 7: Pharmacokinetics (Solution Formulation): Linear PK with Low Variability
Pharmacokinetics (Solution Formulation) Linear PK with Low Variability SAD MAD T1/2 = 20-24 hrs (supports QD dosing) Mean + SD 7
Slide 8: Pharmacokinetics (Solution vs. Gelcap Formulation): Similar PK
Pharmacokinetics (Solution vs. Gelcap (Ph2) Formulation) Similar PK with Low Variability: Ph2 Formulation Confirmed Gelcap relative bioavailability ~85% Mean + SD 8
Slide 9: Biomarkers - Sex Hormone Binding Globulin
Biomarkers - Sex Hormone Binding Globulin Dose Dependent Increase in SAD, MAD MAD Mean + SEM 9
Slide 10: Biomarkers – Atherogenic Lipids (LDL, Apo-B, Triglycerides)
Biomarkers – Atherogenic Lipids (LDL, Apo-B, Triglycerides) Dose Dependent Decrease in SAD, MAD LDL (MAD) Apo-B (MAD) Mean + SEM 10
Slide 11: Biomarkers – Thyroid Hormones
Biomarkers – Thyroid Hormones Dose Dependent Decrease in SAD, MAD MAD TSH Total T4 Total T3 All mean thyroid hormone levels in normal range for doses ≤0.6 mg Mean + SEM 11
Slide 12: Summary
Summary • Single ALG-055009 doses up to 4 mg and multiple doses up to 1 mg x 14 days were well tolerated in Study ALG-055009-301 – No concerning TEAEs, labs, EKGs, vital signs, physical exams – No evidence of clinical hyper- or hypo-thyroidism • ALG-055009 showed favorable PK after single, multiple
Slide 13: Acknowledgments
Acknowledgments • We wish to thank – Study subjects for their participation – Biotrial (study site) and their staff – Additional Aligos team members › Genevieve Harrington › Chris Burnett › Meenakshi Venkatraman › Dinah Misner › Doug Clark 13