The DSMB is a panel of experts not affiliated with the Company nor involved in the conduct of the trial who are tasked with monitoring the safety of subjects enrolled. The panel recently met to review safety data of all enrolled subjects who had completed the trial. The feedback from the committee to the Company was positive. First, the experts concluded that there were no safety concerns and that the clinical trial should continue as per the protocol. Second, in reviewing the drug levels in subjects, there were no issues noted and the results appeared consistent across all subjects. Finally, the panel congratulated the company for a trial that has run so smoothly.
"We are pleased that the independent DSMB has determined that our NASH-CX trial is being conducted in a safe, consistent and efficient manner," said
The NASH-CX trial enrolled 162 biopsy-confirmed NASH cirrhosis patients into the treatment phase and, after only 11 subjects dropped out of the study, there are 151 potential patients completing the trial. Enrolled patients are receiving either 8 mg/kg or 2 mg/kg of GR-MD-02 or placebo every other week for 52 weeks, for a total of 26 infusions.
The primary study endpoint is a reduction in hepatic venous pressure gradient (HVPG), which is a measure of portal pressure and is correlated with patient outcome in this patient population. Patients treated with GR-MD-02 will be evaluated to determine the change in HVPG as compared to patients treated with placebo. Key secondary endpoints include liver biopsy with qualitative fibrosis staging and fibrosis quantification, measurement of liver stiffness (FibroScan®), and assessment of liver metabolism (13C-methacetin breath test, Exalenz), as well as multiple serum biomarkers of fibrosis. More information on the NASH-CX trial may be found in a post on Dr. Traber's blog, CEO Perspectives and at www.clinicaltrials.gov.
"NASH cirrhosis, and indeed all causes of cirrhosis, represent a large unmet medical need with no currently approved medical therapies," said
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic fatty liver disease (NAFLD) has become the most common disease of the liver, generally associated with the rise in obesity rates. NAFLD is characterized by the presence of fat in the liver in people who consume little or no alcohol, and when associated with inflammation and cell damage is called non-alcoholic steatohepatitis (NASH). Over time, patients with NASH can develop fibrosis, or scarring of the liver, which may progress to severe fibrosis, called cirrhosis. Approximately one in four people in the world have NAFLD, with 5% of those developing cirrhosis, and 2% eventually dying of the disease. These data translate into ~20,000,000 liver-related deaths among patients currently alive with NAFLD. There are no drug therapies approved for the treatment of NASH, liver fibrosis, or cirrhosis, for which liver transplant is the only treatment available. A recent analyst estimate indicated that by 2025 the worldwide market for NASH treatments could approach
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on management's current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin's development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with advanced fibrosis and/or cirrhosis. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company's current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin's drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to complete or further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin's business, see the Company's Annual Report on Form 10-K for the year ended
Jack Callicutt, Chief Financial Officer (678) 620-3186 email@example.com
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