FG-3019 is a recombinant fully human antibody designed to bind and neutralize connective tissue growth factor (CTGF). CTGF is implicated as a central mediator of many pathological mechanisms that contribute to the development of common complications of diabetes including diabetic nephropathy. Diabetic nephropathy, a progressive kidney disease in which the ability of the kidneys to filter blood and produce urine declines over many years, is characterized by the presence of proteins in the urine and fibrosis (persistent and excessive scarring).

CTGF is barely detectable in normal kidneys but is highly correlated with proteinuria, and levels of CTGF track the progression of kidney disease in people with type 1 and type 2 diabetes. A growing body of scientific evidence further suggests an active role of CTGF in early- and late-stage pathological aspects of diabetic nephropathy including the mediation of damage resulting from hyperglycemia and hypertension, leading to proteinuria and fibrosis.

Preclinical studies have indicated that treatment with FG-3019 can block fibrotic scarring in models of kidney disease. In these models, the structural integrity of the glomeruli (the filtering units of the kidney) and of the tubules (the concentration and absorption structures of the kidney) is preserved, and kidney function remains in tact.

Development Status
FG-3019 is being developed for the treatment of fibrotic diseases and for diabetic complications. FibroGen has completed a Phase 1 study of FG-3019 in patients with idiopathic pulmonary fibrosis and a Phase 1b safety study of FG-3019 in diabetic patients with microalbuminuria (incipient nephropathy).

Read more about the role of CTGF in diabetic nephropathy and FibroGen's anti-CTGF therapeutic approach.