Galectin Therapeutics presents NAVIGATE trial results at AASLD

Galectin Therapeutics (GALT) presented a poster and will deliver an oral presentation of the NAVIGATE study analysis at the American Association for the Study of Liver Diseases, AASLD, 2025 Annual Meeting. The Phase 2 NAVIGATE trial evaluated belapectin, a proprietary galectin-3 inhibitor, in patients with compensated MASH cirrhosis and portal hypertension. The global Phase 2b NAVIGATE trial was a randomized, double-blind, placebo-controlled study evaluating the galectin-3 inhibitor belapectin in 355 patients with compensated MASH cirrhosis and portal hypertension confirmed by non-invasive markers and baseline endoscopy. Patients were randomized 1:1:1 to receive intravenous belapectin at 2 mg/kg or 4 mg/kg of lean body mass or placebo every other week for 18 months. When patients were stratified using FDA-approved Enhanced Liver Fibrosis score cutoffs, belapectin 2 mg/kg demonstrated a consistently lower incidence of new varices across all fibrosis categories, with the largest reduction observed among patients with ELF greater than11.3, representing those at highest risk for liver complications.