Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis - Seite 2

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 (Phase 3). 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.

Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, said: “The fifth positive recommendation of the DSMB to continue the trial without any modification confirms that our NAVIGATE study remains on track for an interim readout by the end of the year. Moreover, the recommendation further strengthens our confidence that belapectin appears generally safe and well tolerated, which is of great importance given the patients in our trial suffer from several co-morbidities and are on multiple medications, which increases the overall risk of severe complications. This safety profile can tip the balance in favor of the drug’s risk-benefit ratio, an essential element to support any drug approval. The innovative design of the NAVIGATE trial is essential to bring new momentum to clinical development in cirrhosis, a field that has not seen enough medical breakthroughs over the past 50 years. I am convinced that we must change the way we do clinical research if we want to bring hope to our patients. Our adaptive design, as well as our clinical efficacy criteria, represent a new way to evaluate cirrhosis treatment and we hope, if we are successful, that this approach will be emulated. The next DSMB meeting, in addition to the evaluation of belapectin profile, will evaluate the results of the interim analysis and provides its recommendation to Galectin Therapeutics. We are excited to continue our journey to bring patients with liver cirrhosis a potentially efficacious and safe treatment.”

The topline results from the Interim analysis of the Phase 2b (Stage 1) portion of NAVIGATE is expected in the fourth quarter of 2024.

About Belapectin
Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH/MASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in MASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE Phase 2b/3 trial (NCT04365868) to evaluate the efficacy and safety of belapectin for the prevention of esophageal varices in MASH cirrhosis. Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.