Galectin Therapeutics (GALT) announced results from its global clinical trial NAVIGATE evaluating belapectin in patients with Metabolic Dysfunction-Associated Steatohepatitis cirrhosis and portal hypertension. The primary endpoint was defined as the prevention of varices, assessed as a composite clinical outcome that included subjects with any varices, those with intercurrent events, or those without an endoscopy or intercurrent events at 18 months. Intercurrent events were defined as any liver-related complication, treatment discontinuation due to adverse events, use of non-selective beta-blockers or GLP-1 agonists for more than 12 months or undergoing a TIPS procedure. The most common intercurrent event was prolonged use of NSBB or GLP-1 agonists. In the intent-to-treat population, while the incidence of varices was 43.2% reduced in the belapectin 2 mg/kg dose group vs placebo, the composite endpoint did not reach statistical significance. The per-protocol population was pre-defined as subjects who completed 18 months of therapy with upper endoscopy performed at both baseline and 18 months. In the PPP, the incidence of varices was reduced by 48.9% in the belapectin 2 mg/kg dose group
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