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Galmed Pharmaceuticals Reports First Half 2014 Financial Results

thereby permitting Galmed to conduct clinical studies for the targeted indication and additional proof of concept studies in the United States in the future.
  • Filed a Fast Track Designation request with the FDA.
  • Published the results of Galmed's Phase IIa trial of aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal.
  • Commenced on schedule, pharmacokinetic and food effect studies in 66 subjects for the higher doses of aramchol that the Company anticipates using in its Phase IIb trial of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH, patients who are also overweight and diabetic.
  • Filed a provisional patent application in the United States for aramchol to treat lipodystrophy, a medical condition characterized by abnormal or degenerative conditions of adipose tissue, or body fat, including the loss of body fat from various regions of the body and its redistribution and accumulation in other areas and for which there is no currently approved medical treatment, based on Galmed's Phase IIa clinical trial of aramchol in 60 non-alcoholic fatty liver disease, or NAFLD, patients, in which a significant reduction in liver fat and improvement of certain metabolic parameters were observed.
  • Independent publication of the importance of the regulation of ABCA1-induced reverse cholesterol transport on the pathogenesis of NASH, which may further support Galmed's belief that aramchol can play a significant role in the pathogenesis of NASH based on Galmed's studies showing the affect of aramchol in increasing ABCA1 activity in in vitro models of human cells by between 300% and 400%.
  • "I am pleased to report that we have completed all short-term milestones that we set for the first half of 2014 at the time of our initial public offering," stated Allen Baharaff, Galmed's Chief Executive Officer. "We are also moving ahead with trial p

    SOURCE Galmed Pharmaceuticals Ltd.
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