Galectin Therapeutics (GALT) (GALT) announced an update on their ongoing clinical study.
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Galectin Therapeutics Inc. (GALT) has terminated its seamless Phase 2b/3 study of belapectin in patients with NASH cirrhosis who are at risk of developing esophageal varices. The trial aimed to show that belapectin could safely delay or prevent these high-risk complications, a major unmet need in liver disease and a key value driver for the company.
The termination was strategic and based on FDA feedback, not on safety concerns. Specifically, Stage 1 was analyzed as a stand-alone trial following FDA feedback. While this was not a safety halt, it is an official termination of the seamless adaptive Phase 2b/3 design. Now, the company plans to pursue the Phase 3 portion separately.
The treatment under review was belapectin, an intravenous drug given every other week, compared against placebo. It is designed to target liver scarring and reduce pressure in the portal vein, with the goal of lowering the chance that veins in the esophagus become swollen and bleed.
This was a randomized, double-blind, placebo-controlled study, meaning patients were randomly placed in either belapectin or placebo arms and neither they nor their doctors knew which option was given. The main purpose was preventive, testing whether belapectin could stop varices from forming rather than only treating complications after they occur.
The study was first submitted on April 24, 2020, as a long-term project in advanced liver disease.
To learn more about GALT’s potential, visit the Galectin Therapeutics (GALT) drug pipeline page.