Galectin Therapeutics Reports the Positive Outcome of the Fourth Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Portal Hypertension Caused by Non-Alcoholic SteatoHepatitis Live

NORCROSS, Ga., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its fourth data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with portal hypertension caused by non-alcoholic steatohepatitis (NASH) liver cirrhosis. NAVIGATE is the first study of its kind and is a global effort that randomized 357 patients in 14 countries on five continents. The main efficacy objective is the primary prevention of esophageal varices. Interim topline data from the Phase 2b portion of NAVIGATE is expected in the fourth quarter of 2024.

Patients enrolled in the study have liver cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed esophageal varices as a complication of portal hypertension. 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.

The objective of this fourth independent DSMB 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.

Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, said: “The fourth positive recommendation of the DSMB meeting is another essential milestone for Galectin Therapeutics and its belapectin program, and for patients affected by liver cirrhosis caused by NASH (also known as Metabolic dysfunction-Associated SteatoHepatitis, or MASH). The study is fully randomized, and we are continuing to collect a large amount of safety data, including patients who have completed up to 36 months of treatment. This fourth recommendation further strengthens our confidence that belapectin can offer a beneficial risk-benefit profile. Because of the cirrhotic process and the multiple co-morbidities of the metabolic syndrome, such as hypertension, type 2 diabetes and obesity, NAVIGATE patients are generally on multiple medications and at risk of severe complications, including infectious events triggered by an immune deficient state. In this medically complex environment, a candidate drug designed for cirrhotic patients must be safe and well-tolerated. Currently, patients with decompensated liver cirrhosis have no hope other than to receive a liver transplantation. A liver transplantation is a complex and expensive procedure, requiring life-long immunosuppression and specialized follow-up, and is dramatically rationed by a global shortage of organs and a lack of access creating unwanted disparities throughout North America and the rest of the world. With the NASH/MASH epidemy and the resulting increasing number of patients that will suffer from liver cirrhosis, the liver organ shortage is only going to get worse, further highlighting the urgent need for new treatments. I again want to take this opportunity to thank patients and their families, investigators and their teams for participating in this innovative study, and the relentless efforts and commitment of the Galectin team.”