Galectin completes enrollment for phase 2 trial of GR-MD-02 in fibrosis patients

GR-MD-02 targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis.

The trial, which has enrolled 30 patients with advanced fibrosis, will last for 16 weeks.

Galectin will evaluate the effect of GR-MD-02 on liver fibrosis by three independent non-invasive tests after the treatment period.

The primary endpoint will be an assessment of fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan), which is a validated MRI protocol developed by Perspectum Diagnostics.

Secondary endpoints will assess liver stiffness, which correlates to the degree of liver fibrosis, as evaluated by magnetic resonance-elastography and by FibroScan.

Galectin Therapeutics president, CEO and chief medical officer Peter Traber said: "This is one of two Phase 2 trials we are conducting in subjects with NASH, and is designed to assess the efficacy of our lead compound GR-MD-02 in patients with NASH with advanced fibrosis (stage 3).

"Since the diagnosis of NASH and the monitoring of the disease are hampered by the need for liver biopsy, in addition to providing proof-of-concept on the efficacy of GR-MD-02, this study explores the utility of three non-invasive measures of fibrosis which may be useful in the design and execution of later stage clinical studies and perhaps have relevance in commercial clinical settings."

The company anticipates to report the top line results of the trial by the end of September.

NASH, also known as fatty liver disease, is estimated to affect up to 28 million people in the US. A recent analyst estimate indicated that the global market for NASH treatments may approach $35bn by 2025.