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FibroGen announced that interim results from an ongoing Phase 2 study evaluating the investigational drug, FG-3019 for the treatment of idiopathic pulmonary fibrosis (IPF) demonstrates that FG-3019 has the potential to stabilize and improve fibrosis in patients with the disease.
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FG-3019 is an investigational therapeutic antibody designed to inhibit the activity of connective tissue growth factor (CTGF).
The open-label Phase 2 study enrolled 53 IPF patients in Cohort 1 with a wide range of disease severity (forced vital capacity (FVC) % predicted of 42.5– 86.0% with mean and median values of 62.5% and 63.2%, respectively).
Participants were treated with FG-3019 at 15 mg/kg every 3 weeks for 45 weeks. Patients who experienced improved, stable, or modest decline in lung function after one year were allowed to continue in the trial for a second year of treatment at the same dose (Cohort 1 extension). A second cohort of patients was added to the trial and treated with FG-3019 at 30 mg/kg (Cohort 2).
The efficacy endpoints of the study include lung function, as measured every three months by change from baseline in forced vital capacity (FVC), and lung fibrosis, as measured every six months by change from baseline in quantitative high-resolution computed tomography (HRCT) analysis of the entire lungs. HRCT was also used to measure total lung capacity (TLC) every six months.
Overall health status was measured using the St. George Respiratory Questionnaire (SGRQ), a survey index used in evaluation of experimental therapies in patients with respiratory diseases.
Observations included:
- 16 patients with baseline FVC% predicted below 55% generally performed poorly in the trial.
- 33 (89%) of the 37 patients with baseline FVC > 55%, completed 45 weeks of treatment.
- Twelve of these patients (36%) had decreased pulmonary fibrosis in week 48 with an HRCT scan (mean decrease 2.83%) in contrast to 21 patients who had stable or increased fibrosis (mean increase 5.24%).
- Forced vital capacity on average increased by 0.02 L (1.28% predicted) in patients with decreased fibrosis, whereas FVC decreased by -0.20 L (-4.24% predicted) in patients with stable or increased lung fibrosis.
- Patients with decreased lung fibrosis had increased total lung capacity.
- Patients with decreased lung fibrosis tended to have improved symptoms when evaluated using the St. George Respiratory Questionnaire.
FibroGen is currently conducting clinical studies of FG-3019 in idiopathic pulmonary fibrosis, pancreatic cancer, and liver fibrosis.
For more information call (415) 978-1200 or visit FibroGen.com.
