Galectin Therapeutics says DSMB recommends continuation of NAVIGATE study

Galectin Therapeutics reported the outcome of its fifth independent data and safety monitoring board meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with cirrhotic portal hypertension caused by Metabolic Dysfunction-Associated SteatoHepatitis. The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications. The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial. This is the first study of its kind in cirrhotic patients with an innovative adaptive design and an innovative primary outcome of efficacy, the prevention of esophageal varices, a clinical marker of portal hypertension which is an essential mechanism underlying the relentless progression of the disease. The adaptive study includes two stages: The Phase 2b portion, or Stage 1, has been fully enrolled with 357 patients who have clinical signs of portal hypertension, no cirrhosis decompensations, and no esophageal varices. Portal hypertension is the consequence of the unrelenting inflammatory and fibrotic process occurring in the liver and dramatically increases the risk of developing esophageal varices, a potentially life-threatening complication of liver cirrhosis. Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo. An interim analysis of safety and efficacy will be conducted once the last patient randomized into Stage 1 has been followed up for 18 months, and has had a second esophago-gastric endoscopy to evaluate for the presence or absence of esophageal varices. The results of this stage 1 interim analysis will determine if the study progresses into the Phase 3 portion of the trial, or Stage 2 , and which of the pre-specified protocol adaptations are to be integrated into this second stage. The Stage 1 interim analysis has three possible outcomes: stop NAVIGATE because of overwhelming efficacy or because of futility, or initiate NAVIGATE Stage 2 because there is a favorable conditional probability of success regarding the final analysis that will take place at the end of Stage 2. In this third scenario, adaptations to be selected include the choice of the best dose of belapectin and the final number of new patients to be randomized for ensuring an adequate study power for the Final Analysis. The topline results from the Interim analysis of the Phase 2b (Stage 1) portion of NAVIGATE is expected in the fourth quarter of 2024.