FibroGen, Inc., recently disclosed potentially groundbreaking results from a Phase 2 clinical trial evaluating the efficacy of the company’s investigational drug FG-3019 in the treatment of idiopathic pulmonary fibrosis (IPF). Data indicated that the monoclonal antibody agent was able to reduce lung fibrosis in a portion of the IPF patients enrolled, to improve overall lung function.
The results were published in the European Respiratory Journal, in an article titled “FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF.”
FG-3019 is a fully human monoclonal antibody that inhibits the activity of the connective tissue growth factor (CTGF), a central mediator in the pathogenesis of fibrosis and a common factor in pathologies that involve progressive fibrosis and excessive scarring, which can result in organ dysfunction and failure.
Primary outcomes of this open-label Phase 2 study (NCT01262001) were to determine the safety and tolerability of FG-3019 in patients with differing degrees of IPF, administered at doses of 15 mg/kg and 30 mg/kg every three weeks for 45 weeks. Secondary outcomes included the drug’s effect on the extent of pulmonary fibrosis, as measured by quantitative high-resolution computed tomography (HRCT); pulmonary function, as measured by forced vital capacity (FVC); and dyspnea. Evaluation and extent of lung fibrosis were assessed at baseline, week 24, and week 48.
FibroGen hypothesized that FG-3019 could reverse lung fibrosis, based on promising evidence obtained in pre-clinical studies.
Study results showed that, while 65 percent of those enrolled had an increase in lung fibrosis, 35 percent exhibited stable or improved fibrosis at week 48. Such improvement correlated with a pulmonary function improvement. Researchers believe this trial is the first to demonstrate improvement in fibrosis in IPF patients.
Moreover, the results indicated that both doses were well-tolerated by participants. Adverse effects were generally mild, with 27 percent of the patients reporting 38 treatment-emergent serious adverse events (SAEs) during the trial.
Based on the results, the company is planning further investigation of FG-3019 in another Phase 2 study, this time placebo-controlled. The clinical trial (NCT01890265) is now recruiting participants at 25 sites across the U.S. and one in Quebec City, Canada. For more information, visit this link.
“To our knowledge, this is the first report of improved pulmonary fibrosis in IPF patients reported in a peer-reviewed journal,” Thomas B. Neff, FibroGen’s chief executive officer, said in a press release. “We believe this exploratory study provides an indication of the therapeutic potential for FG-3019 in interstitial lung disease and other conditions characterized by the fibrotic process. Many of the subjects in this study responding to FG-3019 have continued on an open label extension for up to 4 years and 9 months. We continue to follow that subset and will seek to report results at an appropriate juncture.”