Clinical trials aim to treat fatty liver disease

Galectin Therapeutics has announced its first Phase 1 clinical trial that will support a planned indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH or fatty liver disease) with advanced fibrosis.

The trial will be carried out in six centres across the US that have extensive experience in carrying out clinical trials in liver disease, following an initial meeting in Atlanta on April 5th.

The Study is planned to enrol the first cohort followed by potential sequential cohorts that receive increasing doses of GR-MD-02, with eight patients in each cohort randomised with a 6 to 2 ratio of drugs to placebo.

As well as receiving GR-MD-02 pharmacokinetics, each patient will have an assessment of over two dozen biomarkers of NASH and fibrosis to evaluate for an early indication of drug effects.

Dr Peter G Traber , president, chief executive officer, and chief medical officer of Galectin Therapeutics, said: "We are delighted to have recruited world class US investigators in NASH to conduct this initial study in our development program to treat liver fibrosis associated with fatty liver.

"The clinical trial will be conducted in patients with NASH and advanced fibrosis who will receive four weekly doses of GR-MD-02 and, while evaluation for safety is the primary objective, a series of biomarkers will be evaluated to assess for early signs of efficacy."

Mr Traber went on to say that the company anticipates obtaining more data from this study than the typical Phase 1 clinical trial.

Galectin Therapeutics is developing a number of carbohydrate-based therapies for the treatment of fibriotic liver disease and cancer based on its understanding of galectin proteins and key mediators of biologic function.

The company is leveraging extensive scientific and development expertise while establishing relationships with external sources to attain cost effective and efficient development.

Posted by Neil Clark