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FibroGen Announces Publication of Phase 2 Study Results Supporting the Potential of FG-3019
Mar. 11, 2016 03:55PM PST
Biotech InvestingFibroGen, Inc. (NASDAQ:FGEN) announced today that the European Respiratory Journal published on-line a manuscript entitled, “FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF,” from a Phase 2 clinical study in subjects with idiopathic pulmonary fibrosis (IPF) treated for 48 weeks with the investigational drug FG-3019, a monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a central mediator of fibrotic disease.
FibroGen, Inc. (NASDAQ:FGEN) announced today that the European Respiratory Journal published on-line a manuscript entitled, “FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF,” from a Phase 2 clinical study in subjects with idiopathic pulmonary fibrosis (IPF) treated for 48 weeks with the investigational drug FG-3019, a monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a central mediator of fibrotic disease.
According to the news:
The exploratory study enrolled patients with a wide range of IPF severity to assess safety and efficacy of FG-3019. While other recent clinical trials in IPF have assessed efficacy in terms of changes in pulmonary function, this Phase 2 open-label study measured efficacy by changes in both pulmonary function, measured by forced vital capacity (FVC), and pulmonary fibrosis, assessed using quantitative high resolution computed tomography (HRCT), the tool employed to confirm diagnosis of IPF. Subjects in two cohorts received intravenous doses of FG-3019 of either 15 mg/kg or 30 mg/kg every three weeks for 45 weeks. The publication provides an analysis of safety and efficacy data from all subjects treated in the study. Of the 89 subjects who received one or more doses, 75 subjects completed 24 weeks and 66 of these subjects completed 48 weeks of treatment and assessment of changes in pulmonary structure and function.
FibroGen Chief Executive Officer, Thomas B. Neff commented:
To our knowledge, this is the first report of improved pulmonary fibrosis in IPF patients reported in a peer-reviewed journal. We believe this exploratory study provides an indication of the therapeutic potential for FG-3019 in interstitial lung disease and other conditions characterized by the fibrotic process. Many of the subjects in this study responding to FG-3019 have continued on an open label extension for up to 4 years and 9 months. We continue to follow that subset and will seek to report results at an appropriate juncture.