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news.FibroGen has announced the presentation of the full data set from a clinical study of patients with idiopathic pulmonary fibrosis (IPF) treated for 48 weeks with the investigational drug FG-3019.
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In the study, lung fibrosis, as measured by quantitative high resolution computed tomography (HRCT), was reduced in a substantial portion of patients who received FG-3019. FG-3019 is a monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), a central mediator of fibrotic disease. The data are being presented in oral and poster presentations at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF).
The study enrolled patients with a wide range of IPF severity to assess safety and efficacy of FG-3019 across a broad spectrum of the disease. 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 and pulmonary fibrosis.
Patients 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 ICLAF presentation provides an updated analysis of efficacy data from all patients treated in the study. Seventy-four (74) patients completed 24 weeks, and 66 of these patients completed 48 weeks of treatment and assessment of changes in pulmonary function and pulmonary fibrosis.
After 24 weeks of treatment, 17 of the 74 patients (23%) had improved fibrosis as measured by quantitative HRCT, and after 48 weeks of treatment, 16 of the 66 patients (24%) had improved fibrosis as measured by quantitative HRCT. FibroGen believes that this is the first trial to demonstrate improved fibrosis in IPF. HRCT is an accurate and reproducible computer-based method to measure fibrotic changes in lung tissue. Recent peer-reviewed publications based on similar quantitative HRCT methods have identified an association between worsening pulmonary fibrosis and mortality in IPF.1 Studies published to date indicate that in untreated IPF patients fibrosis is at best stable but typically worsens over time.
Changes in fibrosis correlated with changes in forced vital capacity, or FVC, at 24 weeks (p=0.0001, r= -0.520) and at 48 weeks (p=0.0001, r= -0.591). On average, patients with improved or stable fibrosis also had improved pulmonary function at week 24 with FVC change of +0.03 liters compared to -0.15 liters for patients with worsening fibrosis (p=0.0001), and at week 48 with FVC change of +0.04 liters compared to -0.23 liters for patients with worsening fibrosis (p=0.0001), indicating improvement in lung function with improvement in lung fibrosis.
The first dose-cohort enrolled patients with a wide range of disease severity: mild to severe (FVC % predicted 45-85%). In the second dose-cohort, enrollment criteria were revised to mild to moderate (FVC % predicted =55%) as most patients with severe disease in cohort 1 dropped out of the trial prior to completion. While an analysis of all patients who completed one year of treatment (N=66) showed a mean FVC change of -0.14 liters, mean FVC change for mild to moderate patients at one year (N=60) was -0.11 liters.
Consistent with previously reported interim results, FG-3019 was well tolerated in treated patients. All patients experienced at least one adverse event. There were 38 SAEs in 24 patients, none of which was considered related to study treatment. Adverse events observed have been consistent with those typically observed in this patient population.
Based on these encouraging data, FibroGen is conducting a randomized placebo controlled Phase 2 trial in IPF which is currently enrolling in the US and will soon be expanded to sites outside of the US.