Galectin Therapeutics Presented NAVIGATE Trial Results at the European Association for the Study of the Liver (EASL) 2025 Congress

Core Insights - Galectin Therapeutics Inc. presented the NAVIGATE study analysis at the EASL 2025 Congress, highlighting the efficacy of belapectin in treating patients with MASH cirrhosis and portal hypertension [1][5] Study Design and Results - The NAVIGATE trial was a global, multicenter, randomized, double-blind, placebo-controlled study involving 355 patients, who were assigned to receive either belapectin at 2 mg/kg, 4 mg/kg, or placebo for 18 months [2] - The primary endpoint was the prevention of varices, with the 2 mg/kg group showing a 49.3% reduction in new varices compared to placebo (p=0.04), while the 4 mg/kg group showed a 39.5% reduction, which was not statistically significant [3][6] Efficacy and Biomarker Analysis - In the per-protocol population, the incidence of varices was 11.3% in the 2 mg/kg group and 13.5% in the 4 mg/kg group, compared to 22.3% in the placebo group [3] - Non-invasive assessments indicated that the 2 mg/kg group had a 66% lower rate of worsening liver stiffness compared to placebo (p=0.02) [4][6] Safety Profile - The safety profile of belapectin was encouraging, with adverse events and serious adverse events rates comparable across all treatment groups, and no drug-related serious adverse events reported [4][6] Expert Commentary - Experts highlighted the significance of the NAVIGATE study results, emphasizing belapectin's potential to address unmet needs in MASH cirrhosis and its consistent benefits observed in the 2 mg dose [5][7] Company Overview - Galectin Therapeutics focuses on developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3, which is involved in various diseases [8]