Galectin Therapeutics Announces Start of Phase 2 Clinical Trial with GR-MD-02 in NASH with Advanced Fibrosis
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the commencement of its Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis (the NASH-FX trial). This 30-patient study is being conducted by Stephen A. Harrison, M.D., FACP, FAASLD, Colonel, Medical Corps U.S.A., Director, Medical Education, Associate Dean, San Antonio Uniformed Services Health Education Consortium, Professor of Medicine, Uniformed Services University of the Health Sciences and Consultant to The Army Surgeon General for Gastroenterological Diseases, San Antonio Military Medical Center. The NASH-FX trial, which focuses on advanced fibrosis, is part of Galectin's overall Phase 2 clinical program with GR-MD-02 in NASH that addresses both advanced fibrosis and cirrhosis.
The NASH-FX trial will enroll 15 NASH patients with advanced fibrosis (stage 3) to receive 8 mg/kg of GR-MD-02 and 15 to receive placebo every other week for 16 weeks, for a total of nine doses. Following the treatment period, the effect of GR-MD-02 on liver fibrosis will be assessed by three independent non-invasive tests. The primary endpoint will be an assessment of fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan®), which is a validated and proprietary MRI protocol developed by Perspectum Diagnostics. Secondary endpoints will evaluate liver stiffness, which correlates to the degree of liver fibrosis, as assessed by magnetic resonance-elastography and FibroScan®. Top-line data is expected to be available in the third quarter of 2016.
"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," said Peter G. Traber, M.D., Galectin's president, chief executive officer and chief medical officer. "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."
More information on the NASH-FX trial may be found in a recent post on Dr. Traber's blog, CEO Perspectives and at www.clinicaltrials.gov.
Commenting on the study, Dr. Harrison said, "NASH is a silent killer of far too many as patients remain asymptomatic, often for many years, until the disease has progressed to advanced fibrosis and cirrhosis. I am very excited to be involved with Galectin's clinical trial program as we work toward finding a compound that might reverse the damage caused by this disease."
The NASH-CX trial is testing two dose levels of GR-MD-02 (8 mg/kg and 2 mg/kg) and will ultimately enroll 156 patients with NASH with cirrhosis who will undergo liver biopsy at the beginning and end of a 52-week treatment period for a total of 26 doses. Patient screening in the NASH-CX trial began in June 2015 and top-line data readout is expected in late 2017. Dr. Harrison also is a lead investigator in the NASH-CX study.
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