Enrollment in NASH-FX trial for advanced fibrosis, NASH complete

Galectin Therapeutics Inc. announced enrollment is complete for its phase 2 NASH-FX trial investigating GR-MD-02, a complex carbohydrate drug that targets galectin-3, for the treatment of nonalcoholic steatohepatitis and advanced fibrosis.

The study, which 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, 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 a press release. In the study, 15 patients with NASH and advanced fibrosis will receive 8 mg/kg of GR-MD-02 every other week and 15 other 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).

“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,” Peter G. Traber, MD, president, CEO and chief medical officer of Galectin, said in the release.

Results of the phase 2 NASH-FX trial are expected to be reported by the end of September 2016, according to the release.

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