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Galectin Therapeutics Reports the Positive Outcome of the Third Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
NORCROSS, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3,
About this update from Galectin Therapeutics Inc.
[{"type":"text","content":"NORCROSS, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its third data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). 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 unrelented 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 third 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 third positive recommendation of the DSMB meeting is an additional important milestone for Galectin Therapeutics and for patients affected by liver cirrhosis caused by NASH. The study is now fully randomized, and we are continuing to collect a large amount of safety data. This third recommendation further strengthens our confidence that belapectin will offer a beneficial risk-benefit profile. Because of the cirrhotic process and the multiple co-morbidities of the metabolic syndrome, as well as the high incidence of type 2 diabetes and obesity, NAVIGATE patients are generally on several medications and at risk of multiple complications, including infectious events triggered by an immune deficient state. In this context, a candidate drug designed for cirrhotic patients must ...