Clinical trial initiated for new fatty liver disease drug

Galectin Therapeutics has initiated a phase 1 clinical trial of a new treatment for patients with fatty liver disease and advanced fibrosis.

The multicenter, partially masked, dose-escalation trial will include 24 patients who receive four weekly doses of GR-MD-02, a complex carbohydrate drug. The study will evaluate safety, efficacy and tolerability of single and multiple doses of the drug, which targets galectin-3, a protein involved in the pathogenesis of fibrosis and nonalcoholic steatohepatitis, according to a press release. The first dosing was performed in a patient treated at Indiana University.

“The successful first patient dosing in the clinical trial of GR-MD-02 is a critical milestone in Galectin’s development program,” Peter G. Traber, MD, president, CEO and chief medical officer of the company, said in the release. “There are currently no treatments for fatty liver disease with advanced fibrosis; this milestone takes us one step closer to bringing a first-in-class treatment to the millions of Americans suffering from this silent epidemic.” Traber estimated that the first eight patients will be enrolled late this summer, with initial results to follow after the 70-day study is concluded.

Earlier this month, the company announced that it had submitted an application with the FDA for Fast Track designation for GR-MD-02.