Galectin Therapeutics Reports Significant Reduction in New Varices with Belapectin in U.S. Patient Population from the NAVIGATE Trial

Core Insights - Galectin Therapeutics, Inc. announced significant results from the NAVIGATE trial, showing a statistically significant reduction in new varices in patients with MASH cirrhosis and portal hypertension treated with belapectin [1][4][8] Group 1: Trial Results - The NAVIGATE trial indicated a 43.2% lower incidence of varices at 18 months for patients treated with belapectin 2 mg compared to placebo, although this was not statistically significant in the intent-to-treat population [2] - In the completer population of 287 patients, the incidence of varices was reduced by 49.3% with belapectin 2 mg versus placebo, achieving a nominal p-value of 0.04 [2] - Further analysis of U.S. completers (n=186) showed a significant 68.1% reduction in varices incidence (p=0.02) for belapectin 2 mg compared to placebo [3][8] Group 2: Market Need and Future Plans - The prevalence of MASH cirrhosis and clinically significant portal hypertension in the U.S. is estimated at around 3 million adults, highlighting the urgent need for new treatments [4][8] - The company is continuing to analyze data from the NAVIGATE trial, including results from approximately 50 patients who completed 36 months of therapy, with additional updates expected in Q1 2025 [4][8] - Galectin Therapeutics is exploring next steps for belapectin development in collaboration with potential partners as ongoing analyses are completed [4]