FG-3019, a fully human monoclonal antibody against Connective Tissue Factor (CTGF), is being developed for the treatment of fibrotic diseases, diabetic complications, and cancer. FG-3019 is designed to block the activity of CTGF, a growth factor that regulates cell proliferation, migration, and adhesion. CTGF is a central mediator of fibrosis, which causes pathological scarring and leads to organ failure in a broad range of diseases. Preclinical studies have indicated that treatment with FG-3019 reduces or inhibits fibrotic scarring and preserves organ structure and function in fibrosis models involving the lungs, liver, and kidneys. Other preclinical research using models of diabetic kidney disease (nephropathy) indicates that FG-3019 has beneficial effects during the early stages of disease progression independent of the fibrotic process. This therapeutic activity is believed to be due to a central role of CTGF in mediating multiple pathways that contribute to the development of diabetic nephropathy over many years and to the gradual destruction of the kidneys. A growing body of evidence also implicates CTGF as a key mediator of tumor-stromal signaling involved in metastasis and the progression of certain cancers, such as pancreatic cancer.

While FG-3019 has the potential to treat many fibrotic disorders, FibroGen is focusing initially on diabetic nephropathy and has completed a phase 1b study in patients with microalbuminuria (incipient nephropathy). FibroGen also successfully completed a phase 1 study of FG-3019 in patients with idiopathic pulmonary fibrosis and filed an IND application to begin clinical testing of FG-3019 in patients with pancreatic cancer. FibroGen plans to begin a phase 1 study of FG-3019 in patients with steroid-resistant focal segmental glomerulosclerosis.

Read more about the development of FG-3019 for the treatment of diabetic nephropathy.

Read more about the development of FG-3019 for the treatment of idiopathic pulmonary fibrosis.

Read more about the development of FG-3019 for the treatment of pancreatic cancer.