Idiopathic Pulmonary Fibrosis (IPF) is a progressive lung disease with a median survival of 2.5 to 3.5 years. No therapy has been shown to prolong survival. This is a Phase 1 study of FG-3019, a human monoclonal antibody against Connective Tissue Growth Factor (CTGF), in patients with mild to moderate IPF. CTGF is implicated in the pathogenesis of IPF and is considered the final common pathway of various profibrotic processes. Preclinical models of lung fibrosis demonstrate that FG-3019 reduces scarring associated with CTGF and excess deposition of matrix components (e.g., fibronectin and collagen).
This open-label, single dose, sequential-group, dose-escalation study is designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of FG-3019 in patients with a well established diagnosis of IPF as defined by ATS criteria. FG-3019 (1 mg/kg, 3 mg/kg, or 10 mg/kg) is administered by intravenous infusion over 2 hours.
Six patients have been treated with 1 mg/kg of FG-3019, and 9 patients with 3 mg/kg of FG-3019. No dose limiting toxicities have been reported. The mean plasma levels of FG-3019 varied from patient to patient but were above the predicted minimum effective concentration based on animal models of fibrosis for approximately 5 days and 13 days for the 1 and 3 mg/kg dose levels, respectively.
These preliminary data suggest that a single 2-hour infusion of FG-3019 (1 mg/kg or 3 mg/kg) is safe and well tolerated.
Further studies of FG-3019 are warranted to evaluate its utility in treating IPF.
G. Raghu, FibroGen, Inc.