FibroGen initiates FG-3019 open-label phase 2 study in idiopathic pulmonary fibrosis

Published on January 13, 2011 at 3:47 AM · No Comments

FibroGen, Inc. today announced initiation of an open-label phase 2 study to evaluate the safety, tolerability, and efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), in individuals with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, fatal lung disease for which there are no FDA-approved therapies.

“Based on evidence from nonclinical studies that FG-3019 can reverse the process of lung fibrosis, we are hopeful that FG-3019 will prove clinically beneficial in patients with IPF.”

The development of IPF is not completely understood but is thought to result from repetitive injury to epithelial cells that line the lungs. This initiates an abnormal wound healing process characterized by activation of cells called myofibroblasts, which produce and deposit excessive amounts of extracellular matrix (ECM). ECM deposition and tissue remodeling are key elements in the process of fibrosis that can eventually severely damage the lungs.

While different traumas and multiple biological factors can initiate the fibrotic process, CTGF is the final common element essential for chronic fibrosis. Studies have shown that CTGF causes transformation of multiple cell types into ECM-producing myofibroblasts and impairs important anti-fibrotic and pro-regenerative repair factors.

Blockade of CTGF, in contrast, has been shown to favor a state of regenerative tissue repair:

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