Hightide Therapeutics Inc · HKEX:2511
Hightide Therapeutics — Technical Presentation (September 2024)
10 slides from Hightide Therapeutics's technical presentation, September 2024
Slide 1: Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Metabolic Liver Disease
Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance Leigh MacConell, Alexander Liberman, Abigail Flyer, Kui Liu
Slide 2: Berberine Ursodeoxycholate (HTD1801): A Gut-Liver Anti-inflammatory Metabolic Modulator
Berberine Ursodeoxycholate (HTD1801) A Gut-Liver Anti-inflammatory Metabolic Modulator • HTD1801 is active through multiple pathways including activation of AMP kinase and inhibition of the NF-κB signaling pathway • HTD1801 enhances the utilization of glucose and fats, thereby reducing insulin level
Slide 3: Background and Aims
Background and Aims Relative Change in LFC (%) • Patients with MASLD and metabolic syndromes are Overall Population at higher risk of clinical outcomes with each additional syndrome1,2 HTD1801 HTD1801 Placebo 500 mg 1000 mg • Hyperinsulinemia is an important risk factor for (N=33) (N=30) (N=27) 0 me
Slide 4: Methods
Methods Primary Endpoint Change in LFC by MRI-PDFF Key Entry Criteria Placebo (N=33) • Presumed MASH with LFC ≥10% Randomized • Serum AST ≥20 U/L and treated 1:1:1 HTD1801 500 mg (N=33) • HbA1c <9.5% N=100 • T2DM and on stable therapy HTD1801 1000 mg (N=34) Day 0 Week 18 • Ongoing studies are evalua
Slide 5: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics FIN ≤40 μIU/mL FIN >40 μIU/mL • Baseline characteristics HTD1801 HTD1801 were generally similar Placebo (n=20) 1000 mg (n=19) Placebo (n=12) 1000 mg (n=8) across insulin subgroups Age, years 59.1 (10.8) 55.0 (10.5) 54.8 (9.5) 45.6 (12.3) ―With the exception
Slide 6: HTD1801 Resulted in Improvements in Liver Fat Content
HTD1801 Resulted in Improvements in Liver Fat Content with Greater Improvements in Patients with Severe Insulin Resistance Liver Fat Content (%) FIN ≤40 uIU/mL FIN >40 uIU/mL -0.6 Relative Change from Baseline 0 -13.0 -15.1 -40.1 LS Mean (SE) -20 -40 6
Slide 7: HTD1801 Resulted in Improvements Across Multiple Liver Parameters
HTD1801 Resulted in Improvements Across Multiple Liver Parameters with Greater Improvements in Patients with Severe Insulin Resistance ALT (U/L) AST (U/L) GGT (U/L) FIN ≤40 uIU/mL FIN >40 uIU/mL FIN ≤40 uIU/mL FIN >40 uIU/mL FIN ≤40 uIU/mL FIN >40 uIU/mL 20 10 50 Mean (SE) Change from Baseline Mean
Slide 8: HTD1801 Resulted in Improvements in Cardiometabolic Parameters
HTD1801 Resulted in Improvements in Cardiometabolic Parameters with Greater Improvements in Patients with Severe Insulin Resistance HbA1c (%) LDL-C (mg/dL) Body Weight (kg) FIN ≤40 uIU/mL FIN >40 uIU/mL FIN ≤40 uIU/mL FIN >40 uIU/mL FIN ≤40 uIU/mL FIN >40 uIU/mL 0.5 20 0 Mean (SE) Change from Baseli
Slide 9: Summary
Summary • Improvements in liver fat content, makers of liver injury, and cardiometabolic endpoints were observed with HTD1801 regardless of baseline insulin levels ―Greater improvements were observed in patients with severe insulin resistance • These data suggest that HTD1801 can alleviate the metab
Slide 10: Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach (poster)
Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Liver Disease and Severe Insulin Resistance Leigh MacConell', Alexander Liberman’, Abigail Flyer?, Kui Liu? RESULTS Baseline Characteristics were Generally Similar Across Insul lin Subgroups FIN 0
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