Galectin Therapeutics (GALT) Earnings Call Presentation

Belapectin for MASH Cirrhosis and Portal Hypertension - Belapectin, a galectin-3 inhibitor, has shown potential in reducing galectin-3 expression and fibrogenic activity in preclinical studies[7] - A Phase 2b trial (GT-026) indicated that Belapectin at a 2 mg dose significantly improved portal pressure (HVPG) and reduced the incidence of esophageal varices in patients without baseline varices at 52 weeks[7] - There are currently no FDA-approved therapies to reverse fibrosis in MASH cirrhosis, highlighting a significant unmet need[7] Market Opportunity and Patient Landscape - MASH cirrhosis affects an estimated 3%-5% of the global population and is considered underdiagnosed[14] - In the U S, approximately 5 million people progress to MASH cirrhosis, with 3.3 million having cirrhosis and portal hypertension[16] - The addressable market in the U S for compensated MASH cirrhosis is significant, with peak Belapectin sales estimated at $18 billion[28] NAVIGATE Trial Results - The NAVIGATE trial design involved randomizing 357 patients with MASH cirrhosis and no varices at baseline into three groups: Placebo, Belapectin 2 mg/kg/LBM, and Belapectin 4 mg/kg/LBM[37] - In the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of varices compared to placebo (11 3% vs 22 3%, p=0 04)[48] - In the U S subgroup of the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of new esophageal varices compared to placebo (6 7% vs 21 0%, p=0 02)[56] - The study showed a favorable safety profile for Belapectin, with adverse events and discontinuation rates comparable to placebo[59]