FG-3019, a first-of-its-kind monoclonal antibody (antibodies made from a single parent cell, aimed at specific cells or “antigens”) targeted at connective tissue growth factor (CTGF), is being tested for its efficacy, safety and tolerability in patients with idiopathic pulmonary fibrosis (IPF). IPF is considered a rare disease, affecting around 40,000 people annually in the U.S. and Canada.
History of FG-3019
FG-3019 is being developed by San Francisco-based FibroGen, which focuses on the development and commercialization of therapeutics for fibrotic conditions and cancers. The main targets of their research include matricellular proteins, such as connective tissue growth factor (CTGF), and matrix assembly enzymes, such as prolyl hydroxylases, for the clinical development of anti-CTGF agents and prolyl hydroxyls inhibitors in therapies to meet unmet demands in medicine.
FG-3019 was granted Orphan Drug status in 2012 by the U.S. FDA, which was a landmark development for FibroGen’s FG-3019. After successful preclinical experiments, a Phase 1 clinical trial with roughly 200 patients with IPF showed positive results in reducing the decline in forced expiratory volume (FEV) and increasing lung capacity, apart from reducing lung fibrosis.
How FG-3019 Works
CTGF is responsible for wound healing and fibrotic activity in the body. Research over the years has shown that it can induce excess fibrosis with the help of TGF-β (Transforming Growth Factor Beta, another protein promoting cell proliferation, growth, and differentiation). Overexpression of CTGF in fibroblasts promotes fibrosis in lungs, kidneys, and skin, and experimental reduction in CTGF has shown reduction of fibrosis in animal models.
FG-3019 works by inhibiting the activity of connective tissue growth factor, effectively slowing the progression of IPF, compared to simply treating the disease’s symptoms.
Next Steps for FG-3019
In March 2016, FibroGen announced that the European Respiratory Journal published an online article about the company’s 48-week open-label Phase 2 clinical trial of the drug, titled “FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF.” The study measured efficacy via changes in both pulmonary function, measured by forced vital capacity (FVC), and pulmonary fibrosis, using high resolution computed tomography (HRCT).
The trial showed that lung fibrosis was reduced in a portion of patients who received FG-3019, and participants with reduced or stable fibrosis showed lung function results that were better overall than others where fibrosis continued to increase.
Another Phase 2 clinical trial is underway for FG-3019 — an open-level, dose-escalation trial testing the efficacy, tolerance, and safety profile of the drug in IPF patients.
The results of these two trials are crucial in determining the viability of the drug for treating IPF.
Note: Pulmonary Fibrosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.