FibroGen has announced the results of a clinical trial that tested a 48-week treatment with the drug FG-3019, an antibody for idiopathic pulmonary fibrosis patients.
The study, “FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF,” was published in the European Respiratory Journal.
The exploratory Phase 2 open-label clinical trial enrolled patients with different severity levels of IPF, with the goal to investigate the effectiveness and safety of FG-3019. Trial endpoints included changes in pulmonary function measured by forced vital capacity (FVC), and changes in pulmonary fibrosis assessed through quantitative high-resolution computed tomography (HRCT).
Patients were treated every three weeks for 45 weeks with FG-3019 at doses of 15 mg/kg or 30 mg/kg. Based on data from pre-clinical trials in radiation-induced pulmonary fibrosis, FibroGen’s proposition was that treatment with FG-3019 would be able to reverse lung fibrosis. The trial endpoints were assessed with quantitative time series of HRCT imaging at baseline, and after 24 and 48 weeks of treatment.
The results showed that although more patients (65 percent) had an increase in fibrosis, 35 percent had stable or improved fibrosis following 48 weeks of treatment with FG-3019. The results also showed that at week 24 and week 48, lung fibrosis improvements were positively correlated with lung function improvements.