The US Food and Drug Administration (FDA) has granted approval to Galectin Therapeutics to commence a first-in-man Phase I clinical study of GR-MD-02, designed for treatment of non-alcoholic steatohepatitis (NASH, or fatty liver disease) with advanced fibrosis.
The approval follows a US Food and Drug Administration (FDA) review of GR-MD-02’s investigational new drug (IND) application.
The trial, entitled "a multi-center, partially blinded, maximum tolerated multiple dose escalation, Phase I clinical trial to evaluate the safety of GR-MD-02 in subjects with non-alcoholic steatohepatitis (NASH) with advanced hepatic fibrosis", will be conducted in up to seven US centres.
The company anticipates that the enrolment and infusion of the first cohort will begin in May 2013.
Galectin Therapeutics president, chief executive officer and chief medical officer Dr Peter Traber said there are currently no approved medical treatments available for patients with NASH and advanced fibrosis.
"This decision by the FDA is an important milestone in our clinical development program to bring forward a treatment option for these patients," Traber said.
"We have recruited a world-class group of clinical investigators and engaged CTI of Cincinnati Ohio, a full service clinical research organisation with extensive experience in liver-related clinical trials, to run the operations of the Phase I clinical trial."