Galectin Therapeutics Announces Top-Line Results of NAVIGATE Clinical Trial Evaluating Belapectin in Patients with Cirrhotic Portal Hypertension Caused by MASH

Core Insights - The NAVIGATE trial results indicate that belapectin, at a dose of 2 mg/kg, showed a statistically significant reduction of 48.9% in the incidence of varices in the per-protocol population compared to placebo, although the primary composite endpoint did not achieve statistical significance in the intent-to-treat population [1][4][15] - Galectin Therapeutics is focused on developing belapectin as a treatment for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis, which currently lacks effective treatment options [2][9] - The company plans to present additional data from the NAVIGATE trial in early 2025, including results from approximately 50 patients who have completed 36 months of treatment [4][10] Company Overview - Galectin Therapeutics is dedicated to developing novel therapies targeting galectin proteins, with belapectin being its lead drug, which has received Fast Track designation from the FDA [2][8] - The company is also exploring additional development programs for cancer immunotherapy and other malignancies, contingent on finding suitable partnerships [2][9] Clinical Trial Details - The NAVIGATE trial was a global, multicenter, randomized, double-blind, placebo-controlled study involving 355 patients across 130 sites in 15 countries [15] - The trial assessed the prevention of varices as a composite clinical outcome, with intercurrent events defined as liver-related complications or treatment discontinuation due to adverse events [15] Safety Profile - Belapectin demonstrated a favorable safety profile, with the incidence of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported [11]