Galmed Pharmaceuticals Ltd. announced results showing significant effects of Aramchol in pre-clinical model of both lung and gastrointestinal (GI) fibrosis. Fibrosis is a common complication of chronic inflammation and can affect all organs and tissues. To date, only limited anti-fibrotic drugs are approved or are in development, most of which have restricting side effects.

Aramchol is a partial inhibitor of SCD1 with distinctive, direct, anti-fibrotic activity demonstrated in several pre-clinical models. Treatment with Aramchol resulted in statistically significant fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment. Findings were seen across all important indicators for the severity of fibrosis including hydroxyproline (a marker for collagen deposition in the fibrotic tissue) P< 0.05, Ashcroft score P < 0.005, % CPA (Percentage Collagen Proportionate Area of the lung) P < 0.001, and immunohistochemistry (type I collagen and a SMA) P < 0.005 for both staining.

Statistically significant improvements were also demonstrated in a validated DSS model of inflammatory bowel disease (IBD). Dextran sulfate sodium (DSS) induced colitis model is widely used because of its similarities with human ulcerative colitis. Clinical improvements were statistically significant at least by p value < 0.05 while in histological score (based on inflammation and colon structural changes) significance was as low as p<0.01.

Aramchol was found to be the most effective compound tested. Control groups included 5-ASA and local steroids which are the gold standards for current treatment. Galmed continues to assess Aramchol's anti-fibrotic effects also in kidney and skin.