Business
Galectin Therapeutics Announces the End of Enrollment of NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis
NORCROSS, Ga., Jan. 05, 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., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced today that in late December 2022, it ended enrollment of 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 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 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: “the Phase 2b portion of NAVIGATE was designed to study approximately 315 patients, randomized (1 to 1 to 1) either to 2 mg/kg of Lean Body Mass (LBM) or 4 mg/kg LBM of belapectin or placebo. We were pleased to close out the screening for this trial in December 2022. Currently, 309 patients have been randomized, and with the remaining patients in screening total randomizations are expected to reach 325 to 340 patients. The final patient is expected to be randomized no later than early March. The treatment period is 18 months; therefore, the results of the interim analysis are expected in the fourth quarter of 2024.” Dr. Stephen A. Harrison, co-principal investigator for NAVIGATE and Chairman, Summit Clinical Research, stated: “completing enrollment in NAVIGATE is an important milestone. This is a critical study for patients with NASH cirrhosis. Demonstrating prevention of progression to esophageal varices in these patients has important implications for long-term patient outcomes. In addition, the primary outcome measure of efficacy, as opposed to liver biopsies, is both practical and clinically relevant.” Mr. Joel Lewis, the Company’s president and Chief Executive Officer sai...