Galectin Enrolls First NASH Cohort

Galectin Therapeutics has completed patient enrollment in the first cohort of a Phase I trial of GR-MD-02. The study, which has successfully enrolled eight patients in the first cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease (NASH) with advanced fibrosis. Intervention in NASH patients with advanced fibrosis, with the intent of reversing the fibrosis, is a potentially important therapeutic approach in this unmet medical need.

The multi-center, partially-blinded trial will be conducted in a total of 24 patients who will receive four weekly doses of GR-MD-02. Each of the three cohorts consists of eight patients, six randomized to receive active drug and two randomized to receive placebo. The study is being conducted at six U.S. centers with extensive experience in clinical trials in liver disease. Two additional centers have been added to aid in the prompt enrollment of the next cohort.

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. In March 2013, the FDA granted GR-MD-02 Fast Track designation for non-alcoholic steatohepatitis (NASH) with hepatic fibrosis, commonly known as fatty liver disease with advanced fibrosis.