SAN FRANCISCO--(BUSINESS WIRE)--FibroGen, Inc., on Monday, September 3rd, presented the most recent results from its Phase 2 trial of FG-3019 as an oral presentation at the European Respiratory Society Annual Congress in Vienna, Austria. The title of the presentation in a late-breaker session of the meeting was “Phase 2 Trial of FG-3019, Anti-CTGF Monoclonal Antibody in Idiopathic Pulmonary Fibrosis: Preliminary Safety and Efficacy Results.”
On May 3, 2012, FibroGen announced an expansion of the ongoing open-label Phase 2 study, in which patients having moderate to severe idiopathic pulmonary fibrosis (IPF) received 15 mg/kg of FG-3019 every three weeks for 45 weeks, to add a second, higher dose group (30 mg/kg) and to offer an additional year of FG-3019 therapy for patients in the first dose group who are exhibiting stable or improved lung function. On July 31, 2012, FibroGen announced that FG-3019 had been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of IPF.
The newly presented results show that, at six months, quantified lung fibrosis scores for more than 60% of subjects demonstrate stability or substantial improvement of lung fibrosis. In a disease for which the fibrosis is expected only to progress in severity, this is a notable finding. The patterns of improved fibrosis changes observed at six months appear to persist so far in nearly all of the subjects for whom 12-month high-resolution computed tomography (HRCT) analyses have been completed. Furthermore, improved or stable lung function showed a strong statistically significant correlation with decreased or stable fibrosis. Preliminary results also show a trend relating improvements in lung fibrosis with increasing blood levels of FG-3019.
In addition, the currently available dataset, complete at six months but incomplete at later time points, shows lung function values that are unchanged or improved from baseline in 31.8% of all patients at week 24, 29.4% at week 36, and 23.8% at week 48. Of those patients who have higher baseline pulmonary function, comparable to typical patients in other IPF trials (baseline Forced Vital Capacity (FVC) % predicted >55%), 38.2% of such patients show unchanged or improved pulmonary function values at week 24, 37.0% at week 36, and 29.4% at week 48. One aim of the higher dose cohort for which FibroGen is currently enrolling subjects is to determine if the pharmacokinetics improvements associated with the higher dose result in a materially greater number of patients with improvements in lung function.
“These are encouraging results in patients for whom fibrosis and pulmonary function are only expected to get worse,” said Thomas B. Neff, Chief Executive Officer at FibroGen. “We continue to meet major milestones in our clinical development plan, and look forward to assessing the results of the second cohort of this study and to advancing the development of FG-3019 for the treatment of this devastating disease.”
Given the promising results observed so far, FibroGen expects to initiate a randomized placebo-controlled trial. If improvements of fibrosis and pulmonary function are confirmed in larger and more rigorous studies, these observations would suggest that FG-3019 may have the capacity in some IPF patients to extend life by delaying or by reversing the normal progression of fibrosis.
About FG-3019
FG-3019 was developed to inhibit the activity of CTGF, a common factor in chronic fibrotic and proliferative disorders in which persistent and excessive scarring can lead to organ dysfunction and failure. In addition to the Phase 2 study of FG-3019 in patients with IPF discusses above, FibroGen is currently conducting clinical studies of FG-3019 in two additional diseases, pancreatic cancer and liver fibrosis. FG-3019 has been well tolerated, with no apparent safety signals, in all studies, involving over 300 patients to date.
About IPF
IPF is a debilitating and life-threatening 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. While patients are often treated with corticosteroids and immunosuppressive agents, no therapies have been clinically proven to improve survival or quality of life. It is thought that stabilization or reversal of lung fibrosis could stabilize lung function and diminish the impact of this devastating disease.
About FibroGen, Inc.
FibroGen, Inc., is a biotechnology company focused on the discovery, development, and commercialization of therapeutics for fibrosis, anemia, cancer, and other serious unmet medical needs. FibroGen’s research into the role of CTGF in various proliferative diseases has led to the development of therapies for the treatment of idiopathic pulmonary fibrosis and cancers, including pancreatic cancer, and other life-threatening disorders. FibroGen’s expertise in the area of prolyl hydroxylase inhibition has led the development of an extensive library of small molecule inhibitors of hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors, including FG-4592 and FG-6874, currently in clinical development for the treatment of anemia. FibroGen also develops and produces recombinant biomaterials, such as human collagens and gelatins, for various purposes, and is currently pursuing the use of recombinant human type III collagen in synthetic corneas for treatment of corneal blindness. FibroGen was founded in 1993 and is based in San Francisco, California.
For more information about FibroGen, Inc., please visit www.fibrogen.com.