Nonalcoholic fatty liver disease, or NAFLD, comprises a spectrum of progressive liver diseases, which currently affects approximately one-third of the western world. It is associated with liver-related morbidity and mortality and with increased risk of cardiovascular disease, type 2 diabetes mellitus, hyperlipidemia (acquired or genetic disorders resulting in elevated levels of lipids circulating in the blood) and abdominal obesity. NASH, one of the manifestations of NAFLD, leads to inflammation, fat and fibrous tissue build-up in the liver, and elevated liver enzymes levels. This can lead to liver cirrhosis, end-stage liver disease and primary liver cancer, or HCC. NASH is predicted to become the leading cause for liver transplantation in the US by 2020. Both genetic predisposition and environmental factors have been implicated in its onset, and inflammation and associated fibrogenesis contribute to its perpetuation.
Tiziana’s intends to administer Foralumab to the small and large intestine via an enteric-coated capsule formulation. Foralumab binds locally to dendritic cells (antigen-presenting cells) lining the GI tract, inducing regulatory T cells supporting immunomodulation of inflammation and fibrosis in the liver.