Galectin Therapeutics Inc. 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. Approximately 9,000 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment 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. The study is fully randomized, and it will be 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 its 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.