Galectin Therapeutics Presented NAVIGATE Trial Results at the American Association for the Study of Liver Diseases (AASLD) 2025 Annual Meeting

Core Insights - Galectin Therapeutics Inc. presented findings from the NAVIGATE study, focusing on the efficacy of belapectin, a galectin-3 inhibitor, in treating patients with compensated MASH cirrhosis and portal hypertension [1][2] Study Overview - The NAVIGATE trial was a Phase 2b randomized, double-blind, placebo-controlled study involving 355 patients, assessing the effects of belapectin administered at doses of 2 mg/kg and 4 mg/kg every other week for 18 months [2] - The study aimed to evaluate the impact of belapectin on the incidence of new esophageal varices and liver fibrosis progression [2][4] Efficacy Results - Belapectin 2 mg/kg showed a significantly lower incidence of new varices compared to placebo, particularly in patients with an ELF score >11.3 (22.7% vs 42.9%) [3][4] - At 18 months, patients receiving 2 mg/kg belapectin achieved a mean reduction of 6.4 ng/mL in Pro-C3 levels, indicating over 50% improvement from baseline [3][5] - The treatment also demonstrated a lower incidence of clinically meaningful worsening in liver stiffness compared to placebo, suggesting a slowing of fibrosis progression [4] Biomarker Analysis - Analysis of YKL-40 showed a ≥20% reduction in a higher proportion of patients treated with belapectin 2 mg/kg compared to placebo (33.8% vs 23.1%), supporting its antifibrotic activity [6][7] - PRO-C4 analysis indicated a ≥20% increase from baseline occurred more frequently in placebo-treated patients (13% vs 3%), reinforcing belapectin's potential to modify disease progression [7] Long-term Outcomes - The reduction in new varices observed at 18 months was sustained through 36 months, with cumulative incidences of new varices at 36 months being 23.4% for placebo, 12.4% for 2 mg/kg, and 16.7% for 4 mg/kg cohorts [8] - The safety profile of belapectin remained favorable, with adverse events comparable across treatment groups and no drug-related serious adverse events reported [9] Expert Commentary - Experts highlighted the long-term NAVIGATE data as significant, noting the sustained improvements in liver stiffness and biomarkers, which suggest a consistent antifibrotic effect [10] - The company expressed optimism about advancing regulatory discussions and exploring partnerships to further develop belapectin, emphasizing its potential to address a significant unmet medical need in MASH cirrhosis [10][11]