Galectin Therapeutics presents NAVIGATE trial results at EASL 2025

Galectin Therapeutics (GALT) presented a late-breaking oral presentation of the NAVIGATE study analysis at the EASL 2025 Congress, on May 10, 2025, in Amsterdam, Netherlands. The NAVIGATE study evaluated belapectin, a galectin-3 inhibitor, in patients with MASH cirrhosis and portal hypertension. The NAVIGATE trial is a global, multicenter, randomized, double-blind, placebo-controlled study. A total of 355 patients were randomized in a 1:1:1 ratio to receive intravenous belapectin at either 2 mg/kg of lean body mass, 4 mg/kg LBM, or placebo every other week for 18 months. The primary endpoint was the prevention of varices, assessed as a composite clinical outcome that included patients who developed any varices, experienced intercurrent events, or lacked an endoscopy or intercurrent events at 18 months. The study evaluated both the intent-to-treat population and a pre-defined per-protocol population or completer population, the latter comprising patients who completed 18 months of treatment with upper endoscopies performed at both baseline and after 18 months of treatment. In the PPP population, the incidence of varices was 11.3% in the belapectin 2 mg/kg group and 13.5% in the 4 mg/kg group, compared to 22.3% in the placebo group. The 2 mg/kg dose demonstrated a 49.3% reduction in incidence of new varices compared to placebo, whereas the 4 mg/kg dose showed a 39.5% reduction in new varices compared to placebo. These clinical findings were further supported by non-invasive assessments. Specifically, liver stiffness, measured via FibroScan, showed a notably lower proportion of patients with worsening in liver stiffness. Notably, the 2mg/kg group significantly outperformed placebo by 66% and 51% respectively in each category. As in prior trials, the safety profile of belapectin remains highly encouraging with incidence of adverse events and serious adverse events comparable across the three cohorts. Rates of discontinuation, adverse events, and serious adverse events were comparable to placebo, with no drug-related SAEs reported in the NAVIGATE trial.