Gil Roth12.20.13
FibroGen has begun enrolling patients in a new Phase II study of FG-3019 in patients who suffer from idiopathic pulmonary fibrosis (IPF). The randomized, double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of FG-3019 in IPF patients. The primary endpoint of the study is lung function, as measured by change in forced vital capacity (FVC). Secondary endpoints include change in lung fibrosis as measured by quantitative high resolution computed tomography (HRCT) scans of the chest. The study is expected to enroll approximately 90 patients for 45 weeks of treatment at centers in the U.S.
The design of this new study builds on positive findings from an ongoing open-label Phase II study of FG-3019 in patients with IPF in which a majority (68% to 71%) of the patients who have completed the trial experienced at most modest declines of FVC (less than 5%), and 24% to 26% of patients who have completed the trial experienced improvement in pulmonary function. In the open-label study, two cohorts with a total of 89 IPF patients were treated 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. To date, FG-3019 has been well tolerated by IPF patients.
The design of this new study builds on positive findings from an ongoing open-label Phase II study of FG-3019 in patients with IPF in which a majority (68% to 71%) of the patients who have completed the trial experienced at most modest declines of FVC (less than 5%), and 24% to 26% of patients who have completed the trial experienced improvement in pulmonary function. In the open-label study, two cohorts with a total of 89 IPF patients were treated 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. To date, FG-3019 has been well tolerated by IPF patients.