Belapectin Shows Promising Reduction in Esophageal Varices in MASH Cirrhosis Patients, Despite Missing Primary Endpoint
Clinical Trial Outcome:
The phase 2b/3 NAVIGATE trial evaluating belapectin in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension missed its composite primary endpoint for the prevention of varices134.
Reduction in Varices:
Despite missing the primary endpoint, belapectin showed a statistically significant reduction (p-value < 0.05) in the development of esophageal varices in the 2 mg/kg dose group compared to placebo in the pre-specified per-protocol population145.
Intent-to-Treat Population:
In the intent-to-treat (ITT) population, the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group versus placebo, but did not reach statistical significance145.
Safety Profile:
Belapectin was overall well tolerated with no safety signals; the incidence of adverse events and serious adverse events were comparable across the three cohorts145.
Future Plans:
Galectin Therapeutics is conducting a full analysis of the NAVIGATE trial data and anticipates providing additional data from approximately 50 patients who have completed 36 months of treatment with belapectin in early 2025145.
Expert Insights:
Experts such as Dr. Khurram Jamil and Dr. Naim Alkhouri are encouraged by the results and believe that belapectin warrants further clinical development as it could become a pivotal therapeutic option for patients with MASH cirrhosis who currently lack treatment options145.
Sources:
1. https://investor.galectintherapeutics.com/news-releases/news-release-details/galectin-therapeutics-announces-top-line-results-navigate
3. https://www.consultantlive.com/view/belapectin-misses-primary-endpoint-phase-3-mash-cirrhosis-portal-hypertension-trial
4. https://www.globenewswire.com/news-release/2024/12/20/3000560/27423/en/Galectin-Therapeutics-Announces-Top-Line-Results-of-NAVIGATE-Clinical-Trial-Evaluating-Belapectin-in-Patients-with-Cirrhotic-Portal-Hypertension-Caused-by-MASH.html
5. https://www.biospace.com/press-releases/galectin-therapeutics-announces-top-line-results-of-navigate-clinical-trial-evaluating-belapectin-in-patients-with-cirrhotic-portal-hypertension-caused-by-mash