Galectin Therapeutics Announces Positive Results from NAVIGATE Clinical Trial

On December 20, 2024, Galectin Therapeutics Inc. (NASDAQ: GALT) revealed the top-line results of its NAVIGATE clinical trial in a recent press release. The trial evaluated belapectin in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH).

In the pre-specified per-protocol population, belapectin exhibited a statistically significant reduction (p-value < 0.05) in the development of esophageal varices in the 2mg/kg cohort compared to the placebo group. While the primary endpoint intent-to-treat population showed a favorable trend in varices incidence, it did not reach statistical significance. The NAVIGATE trial, registered under NCT04365868, was a global study conducted across 130 sites in 15 countries. 355 patients were randomized to receive belapectin at different doses or a placebo every other week for 18 months. The trial evaluated the prevention of varices as the primary endpoint. In the per-protocol population, the belapectin 2 mg/kg group showed a significant reduction of 48.9% in varices incidence compared to placebo, supported by non-invasive measures indicating lower liver stiffness. The safety profile of belapectin remained favorable with comparable adverse event rates across all cohorts. Dr. Khurram Jamil, Chief Medical Officer at Galectin Therapeutics, expressed encouragement by the results seen at 18 months and emphasized the ongoing data analysis. Joel Lewis, CEO of Galectin Therapeutics, highlighted belapectin’s potential as a therapy for patients with MASH cirrhosis and portal hypertension. The Company stated that the lack of increased efficacy at higher belapectin doses may be due to saturable binding dynamics and interactions with Galectin-3 proteins. Detailed analysis of the trial data, including long-term data from patients, is expected in early 2025. Galectin Therapeutics focuses on developing therapies to address chronic liver disease and cancer, with belapectin being a leading drug targeting the galectin-3 protein. The Company plans to provide further clinical updates and determine the next steps for belapectin’s development based on upcoming data. Forward-looking statements in the press release caution that actual results could differ from those discussed due to various factors, including regulatory requirements and trial outcomes. Galectin Therapeutics remains optimistic about belapectin’s potential pending further analysis and upcoming clinical updates.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Galectin Therapeutics’s 8K filing here.

Galectin Therapeutics Company Profile

Galectin Therapeutics Inc, a clinical stage biopharmaceutical company, engages in the research and development of therapies for fibrotic, cancer, and other diseases. Its lead product candidate is belapectin (GR-MD-02) galectin-3 inhibitor, that is in Phase 2b/3 clinical trial, to prevent esophageal varices in patient with non-alcoholic steatohepatitis (NASH) cirrhosis; and Phase 2 clinical trial for the treatment of liver fibrosis, as well as severe skin disease, and melanoma and head and neck squamous cell carcinoma.