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Clinical Trials

Date: 2016-03-30

Type of information: Results

phase: preclinical

Announcement: results

Company: Galmed Pharmaceuticals (Israel)

Product: aramchol

Action mechanism: bile-acid conjugate. Aramchol is a conjugate of cholic acid and arachidic acid. This is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Aramchol affects liver fat metabolism and has been shown in a phase IIa clinical study to significantly reduce liver fat content as well as improve metabolic parameters associated with fatty liver disease.

Disease: NASH (non-alcoholic steatohepatitis)

Therapeutic area: Hepatic diseases - Liver diseases

Country:

Trial details:

Latest news: • On March 30, 2016, Galmed Pharmaceuticals announced 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), as 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, "AramcholTM 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, AramcholTM 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™." Full data regarding this pre-clinical research will be submitted to the 2016 AASLD Liver Meeting in Boston.  

Is general: Yes