Belapectin Shows Promise in Preventing Esophageal Varices in MASH Cirrhosis Patients
核心洞察
Galectin Therapeutics' belapectin demonstrated a statistically significant reduction in new esophageal varices (搜索) development in MASH cirrhosis (搜索) patients in the per-protocol population of the NAVIGATE Phase 2b trial.
The galectin-3 (搜索) inhibitor showed favorable effects on fibrosis markers and liver stiffness measures, with fewer patients experiencing clinically meaningful worsening compared to placebo.
Results published in Hepatology and presented at EASL 2026 support belapectin's potential as a disease-modifying therapy for portal hypertension (搜索) in an area with significant unmet medical need.
Galectin Therapeutics has reported promising results from its NAVIGATE Phase 2b clinical trial, demonstrating that belapectin, a galectin-3 (搜索) inhibitor, significantly reduced the development of new esophageal varices (搜索) in patients with MASH cirrhosis (搜索) and portal hypertension (搜索). The findings, published in the AASLD flagship journal Hepatology and presented at the European Association for the Study of the Liver (EASL) Congress 2026, represent a potential breakthrough in treating a condition with substantial unmet medical need.
Clinical Trial Results
The NAVIGATE trial evaluated belapectin in patients with MASH cirrhosis (搜索) and portal hypertension (搜索) without esophageal varices (搜索) at baseline over an 18-month treatment period. Belapectin 2 mg/kg demonstrated a statistically significant reduction in new varices development in the per-protocol population (p=0.04), with a numerical reduction observed in the full analysis set compared to placebo.
The study also revealed significant improvements in liver stiffness measures at multiple timepoints. Notably, fewer belapectin-treated patients experienced clinically meaningful worsening of liver stiffness (>30% increase) versus placebo (11.7% vs. 23.9%; p=0.03). At 18 months, a greater proportion of belapectin-treated patients improved to the no/low-risk Baveno category relative to baseline compared with placebo (p=0.0073).
Mechanistic Insights
Data presented at EASL 2026 provided important mechanistic insights into belapectin's effects on disease progression. The oral presentation demonstrated belapectin's impact on fibrosis modulation through changes in the Pro-C3/CTX-III ratio, a marker of fibrogenesis balance. Favorable shifts in this ratio were associated with reduced varices development and improvements in broad markers of fibrosis including liver stiffness measure and other fibrosis markers.
"The analyses presented at EASL 2026 provide important new insight into how belapectin may modify disease progression in patients with advanced MASH cirrhosis (搜索) and portal hypertension (搜索)," said Dr. Khurram Jamil, Chief Medical Officer of Galectin Therapeutics. "The oral presentation demonstrates a mechanistic link between modulation of fibrogenesis balance, as reflected by the Pro-C3/CTX-III ratio, and reduced varices development in high-risk patients."
Safety Profile and Clinical Significance
The trial demonstrated that belapectin was generally safe and well tolerated throughout the study period. Key markers of fibrosis, including Liver Stiffness Measure results, were aligned with the clinical findings, supporting the drug's favorable safety profile.
Prof. Naga Chalasani, David W. Crabb Professor of Gastroenterology and Hepatology at Indiana University School of Medicine and principal investigator for the NAVIGATE program, emphasized the clinical relevance of these findings. "These findings provide clinically meaningful evidence for the potential role of belapectin in addressing portal hypertension (搜索) and reducing the risk of clinically significant complications in patients with MASH cirrhosis (搜索)," he stated.
Addressing Unmet Medical Need
The results are particularly significant given that there are currently no approved therapies for the prevention of varices or treatment of portal hypertension (搜索) in patients with MASH cirrhosis (搜索). Liver cirrhosis (搜索) represents one of the most pressing medical needs and a significant drug development opportunity.
The poster presentation analyzing risk reduction in clinically significant portal hypertension (搜索) was designated a TOP Poster at EASL 2026, recognizing it among the best abstracts in the Portal Hypertension session. This recognition underscores the scientific community's interest in belapectin's potential therapeutic benefits.
Drug Development Context
Belapectin targets galectin-3 (搜索), a key mediator of fibrosis and inflammation, and has received Fast Track designation from the U.S. Food and Drug Administration. The drug is being developed as a potential therapy to address complications of MASH cirrhosis (搜索), the most advanced form of MASH-related fibrosis.
The consistency of findings across multiple biomarkers and clinical outcomes strengthens the evidence supporting belapectin's disease-modifying potential. As Dr. Jamil noted, "The consistency of findings across the dataset strengthens the overall evidence supporting belapectin's disease-modifying potential."