FibroGen, Inc. (FibroGen) announced today the presentation of clinical
data at the American Thoracic Society (ATS) International Conference
supporting the safety and efficacy of FG-3019 in patients with
idiopathic pulmonary fibrosis (IPF), a debilitating and life-threatening
lung disease for which there is currently no approved therapy in the
United States. FG-3019 is an investigational monoclonal antibody that
inhibits the activity of connective tissue growth factor (CTGF), a
central mediator of fibrotic disease.
Today's presentation focused on patients in the first cohort of a Phase
2a study of FG-3019 who completed one year of treatment as well as
patients in the first cohort who continued to receive treatment for a
total of two years.
Consistent with previous results, FG-3019 was well tolerated in IPF
patients treated for up to two years. No serious adverse events were
considered to be related to treatment with FG-3019.
The study evaluated changes in pulmonary function, changes in pulmonary
fibrosis, and patient reported outcomes, a measure of overall patient
quality of life. The study employed quantitative high resolution
computed tomography, or HRCT, which is an accurate and reproducible
method to measure changes in the percentage of the patient's lung tissue
that is fibrotic. Recent publications based on similar quantitative HRCT
methods have identified an association between worsening pulmonary
fibrosis and mortality in IPF.1
The study enrolled patients with a wide range of IPF severity to assess
safety and efficacy across a broad spectrum of the disease. Efficacy
data from patients with mild to moderate disease (n=37) were analyzed in
the presentation, a patient population similar to those evaluated in
other recent IPF clinical trials. Thirty-three of these patients
completed 48 weeks of treatment.
After 48 weeks of treatment, twelve of the 33 patients (36%) had
improved fibrosis as measured by quantitative HRCT. Prior to this
finding, improved fibrosis had never been reported in IPF patients. An
additional two patients had stable fibrosis for a total of 14 patients
(42%) with improved or stable fibrosis.
Change in forced vital capacity, or FVC, also correlated with changes in
fibrosis (p=0.005, r= -0.476) at 48 weeks. Patients with improved or
stable fibrosis also had improved pulmonary function at week 48 with FVC
change of +0.05 liters compared to -0.24 liters for patients with
worsening fibrosis (p=0.006).
The St. George's Respiratory Questionnaire (SGRQ) is often used in IPF
trials to assess changes in patients' perceptions of disease impact on
their quality of life. Improvements in the SGRQ symptoms score
correlated significantly with improvements in fibrosis at both 6 months
and 12 months (p<0.05) assessments.
Eighteen of the 33 patients who completed the primary study enrolled in
an extension study to continue FG-3019 treatment for a second year.
Fourteen of these patients completed the second year of treatment. Four
of the 14 evaluable patients experienced a prolonged improvement in
pulmonary function through the second year of study, with average change
in FVC from the original baseline of +0.2 liters. Six had modest decline
in pulmonary function (average change from baseline after 2 year of -0.2
liters) and another 4 showed a severe decline (average change in FVC
from the original baseline of -0.6 liters) at the end of the second
year. Patients who experienced modest decline or improvement in FVC
experienced only a modest increase in fibrosis, whereas those who
experienced a severe decline also showed the greatest increase in
1. Maldonado et al. Eur Resp J 2014; Oda et al. Respiratory Research
About Idiopathic Pulmonary Fibrosis (IPF)IPF is a lung
disease characterized by a progressive scarring of the lungs that
diminishes functional lung volume and hinders oxygen uptake. The cause
of IPF is not known, and approximately two-thirds of IPF patients die
within five years after diagnosis. There are currently no FDA-approved
treatments for IPF. Patients are typically treated with corticosteroids
and immunosuppressive agents. However, none of these agents have been
clinically proven to improve survival or quality of life.
About FG-3019FG-3019 is an investigational therapeutic
antibody developed by FibroGen to inhibit the activity of connective
tissue growth factor (CTGF), a common factor in chronic fibrotic and
proliferative disorders characterized by persistent and excessive
scarring that can lead to organ dysfunction and failure. FibroGen is
currently conducting clinical studies of FG-3019 in idiopathic pulmonary
fibrosis, pancreatic cancer, and liver fibrosis. FG-3019 has been well
tolerated, with no apparent safety signals, in more than nine clinical
studies and more than 340 treated patients to date.
About FibroGenFibroGen is a privately-held biotechnology
company focused on the discovery, development, and commercialization of
therapeutic agents for treatment of fibrosis, anemia, cancer, and other
serious unmet medical needs. FibroGen's FG-3019 fully human monoclonal
antibody is in clinical development for treatment of idiopathic
pulmonary fibrosis and other proliferative diseases, including
pancreatic cancer and liver fibrosis. Roxadustat (FG-4592), FibroGen's
small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl
hydroxylase, is currently in clinical development for the treatment of
anemia. FibroGen is also currently pursuing the use of proprietary
recombinant human type III collagens in synthetic corneas for treatment
of corneal blindness. For more information please visit: www.fibrogen.com.
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