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Galectin Therapeutics Provides Final Randomization Status of NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
NORCROSS, Ga., March 02, 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 02, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced that in late December 2022, it ended the enrollment of new patients into NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The last patient was randomized into NAVIGATE at the end of February 2023. In order to be randomized, the screening process documented the presence of clinical signs of portal hypertension and validated the absence of esophageal and/or gastric varices by a central adjudication of video recording of upper esophago-gastric endoscopies. NAVIGATE has randomized 357 patients, above its initial objective of approximately 315 patients. NAVIGATE is the first study of its kind and is a global effort that recruited patients in 14 countries and on five continents. The main efficacy objective is the primary prevention of esophageal varices. Patients enrolled in the study have cirrhosis caused by NASH and, because of the advancing cirrhotic process, have already developed portal hypertension but have not yet developed dilated veins in the esophagus known as esophageal varices, a clinically concerning 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. Dr. Pol Boudes, M.D., Chief Medical Officer of Galectin Therapeutics, said: “We are very pleased to achieve our randomization objective for this study, the first of its kind to address liver cirrhosis with portal hypertension. The treatment period of the phase 2b portion is 18 months; therefore, the topline results of the interim analysis are expected in the fourth quarter of 2024. This will be a very important milestone for patients affected by this disease and for their families, and we hope to demonstrate a positive risk benefit for belapectin.” Mr. Joel Lewis, the Company’s President and Chief Executive Officer said: “We are gratified to reach this important milestone. The last randomization will allow us to focus on efficiently executing our program and other stated goals for the res...