FibroGen announced that FG-3019 has been granted Orphan Drug Designation by the FDA for the treatment of idiopathic pulmonary fibrosis (IPF).

FG-3019 has been the subject of clinical studies involving over 200 patients to date, including a Phase 1 study of patients with IPF. FibroGen is currently conducting an open-label Phase 2 study of FG-3019 in patients with IPF as well as two other clinical studies in different diseases.

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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