Galmed’s Aramchol shows “significant” anti-fibrotic effects in PSC models

Galmed (GLMD) announced results showing significant effects of Aramchol in pre-clinical models of primary sclerosing cholangitis, or PSC. Fibroinflammatory cholangiopathies, such as PSC and primary biliary cholangitis, are characterized by cholestatic injury, inflammation and fibrosis-induced obstruction of ducts, driving disease-related complications. Aramchol, an SCD-1 inhibitor, both attenuated and prevented biliary fibrosis in mouse models of PSC. Aramchol led to a significant inhibition of TGFbeta-induced hepatic fibrosis pathways while upregulating peroxisome proliferator activated receptor signaling. PSC carries a 20% lifetime risk for the development of colangiocarcinoma, or CCA. The PSC fibrotic environment is tumor-promoting and in its turn, CCA triggers a strong fibrotic reaction which contributes to the lack of efficacy of therapy. Aramchol demonstrated significant improvement in liver fibrosis. Aramchol’s effect in the prevention and treatment of hepatic and biliary fibrosis, along with its safety profile in clinical trials, provide the rationale for assessing Aramchol in further clinical studies in patients with biliary fibrosis, particularly PSC, and hepatic cancers, such as CCA and HCC.