Galectin Therapeutics announced positive results from its NAVIGATE trial of belapectin, a galectin-3 inhibitor, for patients with MASH cirrhosis and portal hypertension. The 2 mg/kg dose of belapectin showed a statistically significant reduction in new varices at 18 months in the per-protocol population, a key indicator of disease progression. Furthermore, the treatment showed a beneficial effect in halting the progression of liver stiffness, measured by FibroScan®.
This news offers a potential breakthrough for MASH cirrhosis patients, a disease area with significant unmet medical needs. Current treatment options are limited, and the development of a therapy that prevents the formation of varices, a common and dangerous complication, would significantly improve patient outcomes and quality of life. The positive impact on liver stiffness further suggests belapectin could slow the progression of the disease itself, offering a potential disease-modifying therapy.
The NAVIGATE trial, a randomized, double-blind, placebo-controlled study, enrolled 355 patients. Analysis of the per-protocol population (N=287) revealed a 49.3% reduction in the incidence of new varices in the 2 mg/kg belapectin group compared to placebo (p=0.04). The 4 mg/kg dose, while showing a trend towards improvement, did not reach statistical significance. Importantly, the safety profile of belapectin remained encouraging, with comparable adverse events and serious adverse events across all treatment arms. Specifically, the 2mg/kg belapectin dosage outperformed placebo in slowing the progression of liver stiffness as measured by a greater than 10 kPa increase from baseline (66% reduction, p=0.02) and a greater than 30% increase from baseline (51% reduction, p=0.03).
These positive results position belapectin as a promising potential therapy for MASH cirrhosis. The data suggests a clear clinical benefit with the 2 mg/kg dose, both in preventing complications and potentially modifying disease progression. While further analysis and potentially larger confirmatory trials may be required, this represents a significant step forward in addressing this serious and prevalent liver disease. The results also strengthen Galectin Therapeutics’ position in the field and may attract further investment or partnerships to advance the development and commercialization of belapectin.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
