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Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Date:7/22/2014

everal metabolic parameters.  The trial's primary efficacy end point was a reduction in liver fat content, without consideration of inflammation or fibrosis. The secondary efficacy end points measured differences between the aramchol-treated group and the placebo group with respect to alterations of liver enzyme levels, levels of adiponectin, homeostasis model assessment scores, and endothelial function.  All endpoints were met and there were no notable changes in biochemical, hematological, cardiovascular or other safety parameters, or any observable serious or drug-related adverse events in the 58 patients who completed the trial either during the three-month treatment period or during the subsequent recovery period.  Galmed further confirmed the appropriateness of a single daily dose of aramachol by pharmacokinetic analysis.

About Galmed Pharmaceuticals Ltd.

Galmed is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs.  Galmed believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading "Risk Factors," included in the registration statement on Form F-1 (File No. 333 -193792), initially filed with the Securities and Exchange Commission, or the SEC, on February 6, 2014 and declared eff
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SOURCE Galmed Pharmaceuticals Ltd.
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