Galectin initiates phase 2 trial of GR-MD-02 for NASH, advanced fibrosis

Galectin Therapeutics Inc. announced it has begun enrolling patients for its phase 2 clinical trial that will be investigating GR-MD-02 for the treatment of patients with nonalcoholic steatohepatitis with advanced fibrosis.

The study, also known as the NASH-FX trial, will focus on advanced fibrosis and is part of Galectin’s overall phase 2 clinical program with GR-MD-02 (Galectin Therapeutics) for NASH, according to the release. In the study, 30 patients with NASH will be enrolled and 15 patients with NASH and advanced fibrosis will receive 8 mg/kg of GR-MD-02 every other week and 15 patients will receive placebo for 16 weeks, totaling nine doses.

The primary endpoint will be an assessment of fibrosis using the LiverMultiScan (Perspectum Diagnostics), according to the release. Secondary endpoints include the evaluation of liver stiffness via magnetic resonance-elastography and FibroScan (Echosens).

“We are delighted to commence the second part of our phase 2 clinical program with GR-MD-02 in NASH with advanced fibrosis and cirrhosis,” Peter G. Traber, MD, president, CEO and chief medical officer of Galectin, said in the release. “Importantly, the NASH-FX trial will employ non-invasive measures as surrogates for NASH with advanced fibrosis. While the goal of this study is to determine the safety and efficacy of GR-MD-02, we also expect this trial to provide important information about the non-invasive diagnostic methods that may be utilized in subsequent studies.”

This phase 2 clinical study will be led by Stephen A. Harrison, MD, FACP, FAASLD, professor of medicine at the Uniformed Services University of the Health Sciences, San Antonio Military Medical Center, Texas, according to the release.

Disclosures: Traber reports being employed by Galectin Therapeutics. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Harrison at the time of publication.