Research & Development

Aramchol

Treatment of NASH

Galmed is developing aramchol as a potentially disease modifying treatment for NASH. aramchol, a conjugate of cholic acid and arachidic acid, 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 NASH. Furthermore, aramchol has been shown to be safe and tolerable, with no severe adverse effects.

Aramchol1

 Aramchol2

Aramchol was initially intended to combine a cholesterol solubilizing moiety (a saturated fatty acid) with a bile acid (cholic acid) acting as a vehicle to enable secretion into bile and entry into the enterohepatic circulation to solubilize bile stones1. However, early in the development, it was observed that aramchol reduced liver fat infiltration in animals fed a high fat, lithogenic diet2. This effect was confirmed in other animal models and the development plan was modified according to these findings, as fatty liver is an unmet need.

Aramchol is now being developed for NASH (currently in Phase IIb). The progress of our clinical studies can me monitored here.

[1] Gilat, T., Somjen G.J., et al. (2001). “Fatty acid bile acid conjugates (FABACs)–new molecules for the prevention of cholesterol crystallisation in bile.

[2] Gilat, T., Leikin-Frenkel, A., et al. (2003). “Prevention of diet-induced fatty liver in experimental animals by the oral administration of a fatty acid bile acid conjugate (FABAC).” Hepatology 38(2): 436-442