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Galmed: Demonstrates Significant Anti-Fibrotic Effect In A

The following excerpt is from the company's SEC filing.

Pre-clinical Model of Fatty Liver Disease

– Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, announced today pre-clinical data demonstrating significant anti-fibrotic activity of Aramchol

in methionine and choline deficient (MCD) diet in mice.

The new pre-clinical studies demonstrated both a statistically significant reduction of inflammation (65% decrease in F4/80, and 80% decrease in CD64), a s well as a statically significant effect on liver fibrosis (70% decrease in Sirius Red). The repeated studies were performed by CIC bioGUNE in Spain under the supervision of Professor José Mato, a notable NASH pre-clinical researcher.

Professor José Mato, CIC bioGUNE General Director, commented on the results of the pre-clinical studies, “Aramchol

showed a potent effect on the hepatic accumulation of fatty acids in the MCD at the high dose (5 mg/kg/day) and much less at the low dose (1 mg/kg/day).” Professor Mato continued, “This data support the operating hypothesis that, at least in this model, Aramchol

acts through two independent mechanisms: The first is an anti-inflammatory mechanism, and the second is through improving lipid metabolism. We are currently investigating transcriptomics and metabolomics data from this study, which may give new insights into the mechanisms that lead to this anti-fibrotic effect of Aramchol

Professor Scott Friedman, Chief, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai in New York and a member of Galmed Scientific Advisory Board also commented, “These results reinforce the potential efficacy of Aramchol

in human NASH, but continued pre-clinical evaluation, use of new models, and elucidation of mechanisms-of-action remain ongoing priorities while we seek to establish Aramchol

’s efficacy in clinical trials in patients with NASH.”

“The reason that we believe these new findings are material, incremental and noteworthy is because we had previously understood that Aramchol

’s primary clinical objective was to treat NASH through its ability to reduce excess liver fat (steatosis), which is commonly understood to be the underlying cause of...