FibroGen announced initiation of a Phase 2 trial of FG-3019 in patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, fatal lung disease for which there are no FDA-approved therapies. This open-label study is expected to enroll 48 patients with progressive IPF, who will receive intravenous infusions of FG-3019 every 3 weeks for 45 weeks. Safety, tolerability, and the effect of FG-3019 on extent of lung fibrosis (as measured by CT scan), lung function, and shortness of breath will be assessed.
FG-3019 is a human monoclonal antibody against connective tissue growth factor (CTGF). CTGF is implicated as a pathogenic factor in IPF. In patients with IPF, CTGF levels are elevated in transbronchial biopsy specimens and in bronchoalveolar lavage fluid.
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