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Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
NORCROSS, Ga., April 14, 2022 (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., April 14, 2022 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its first 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 recruits patients over 15 countries and five continents. The study main efficacy objective is the primary prevention of esophageal varices. 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 first independent DSMB was to review the emerging tolerance and safety profiles of belapectin. Based on its deliberation, the DSMB concluded that NAVIGATE can continue as designed, without modifications. Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, said: “The positive recommendation of the DSMB meeting is a very important milestone for Galectin Therapeutics and for patients affected by liver cirrhosis due to NASH. This recommendation confirms that belapectin appears safe and well tolerated to date. Such a safety profile is an essential asset for a candidate drug designed for cirrhotic patients, as they are fragile, may need adjustment or interruption of common drug treatments, and are also frequently immune-compromised. Currently patients with decompensated liver disease, have no other hope than to receive a liver transplantation. A transplantation is a complex and expensive procedure, requiring life-long immunosuppression and specialized follow-up, and is further affected by a global shortage of organs. With the NASH 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 nee...