US-based FibroGen has initiated patient enrolment in a new Phase II clinical study, designed to evaluate the safety and efficacy of FG-3019 in idiopathic pulmonary fibrosis (IPF) patients.
The double-blind study is expected to enrol up to 90 patients for 45 weeks of treatment at centres in the US.
The primary endpoint of the randomised, placebo-controlled study is lung function, as measured by change in forced vital capacity (FVC).
The secondary endpoints include change in lung fibrosis as measured by quantitative high-resolution computed tomography scans of the chest.
The Phase II study randomises patients at a ratio of 1:1 to receive either FG-3019 or a matching placebo through intravenous infusion every three weeks over a 45-week period.
The new study design builds on the promising findings from an ongoing, open-label Phase II study of FG-3019 in patients with IPF. Two cohorts with a total of 89 IPF patients have been treated in the Phase II study with two different doses of FG-3019.
Results suggest a strong correlation between improved fibrosis and improved pulmonary function, as well as trends for improved patient-reported outcomes associated with improved fibrosis.
Until now, FG-3019 has been well-tolerated by IPF patients.
FibroGen chief medical officer Dr Frank H Valone said: "The observation of IPF fibrosis improvement is without clinical precedent and directly challenges the widely held view that improvement in fibrosis is not a therapeutic possibility.
"We believe that our study will continue to support the strong and growing interest in our FG-3019 programme within the clinical community, and we are working closely with investigators to identify and enroll eligible subjects afflicted with idiopathic pulmonary fibrosis."
According to the company, patients in the FG-3019 treatment group whose lung function stabilises or improves and all patients in the placebo group will be eligible to participate in an unblinded treatment extension for an additional 45 weeks.
FibroGen has developed FG-3019, an investigational therapeutic antibody, to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders.
FibroGen is currently conducting clinical trials of FG-3019 in idiopathic pulmonary fibrosis, pancreatic cancer, and liver fibrosis.
The drug has been well tolerated, with no apparent safety signals, in more than nine clinical studies and more than 350 treated patients to date.
Image: A chest radiograph of a patient with idiopathic pulmonary fibrosis. Photo: courtesy of IPFeditor.