Nephrology Dialysis Transplantation Reports Phase 2 Data of Investigational Orally Active HIF-PHI Roxadustat (FG-4592) Shows Improved Hemoglobin Levels in Non-Dialysis CKD Subjects With Anemia

SAN FRANCISCO, Aug. 12, 2015 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today announced that Nephrology Dialysis Transplantation has published encouraging Phase 2a safety and efficacy data for roxadustat, an orally active potent hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment of anemia associated with chronic kidney disease (CKD). In a multicenter, randomized, placebo-controlled trial that was conducted in non-dialysis subjects with anemia associated with stage 3 or 4 CKD, roxadustat produced dose-dependent increases in hemoglobin (Hb) within 14 to 25 days.

"To our knowledge, this publication is the first peer-reviewed article to feature a HIF-PHI, a new class of drug, in a multi-dose study of patients with anemia. Data from the study offer insight into the potential ability of roxadustat to treat CKD-associated anemia," said Anatole Besarab, MD, executive director, clinical research at FibroGen and lead author.

Anemia is a common complication of kidney disease. While the risk of hospitalization, heart disease and death is higher for patients with kidney disease than for those without kidney disease, the risk of these events is even higher for patients with both anemia and kidney disease. Anemia can be treated in people with kidney disease, but often the disease is not treated in patients who have not yet begun dialysis. One of the approved therapies for anemia, erythropoietin analogues, has been the standard approach for managing the anemia of kidney disease and reducing the need for red blood cell (RBC) transfusion. However, the safety of using erythropoietin analogues to treat the anemia of kidney disease has been questioned. In controlled trials, greater risks for death, serious adverse cardiovascular reactions such as hospitalization for heart failure, and stroke occurred when erythropoietin analogues were administered targeting Hb levels >13 g/dL.

Untreated or delayed treatment of CKD-associated anemia can be linked to a higher likelihood of hospitalization, red blood cell transfusion, and mortality rates. This study evaluated 116 subjects who were living with CKD and concomitant anemia but were not undergoing dialysis. Of these 116 subjects, 96 were evaluable for efficacy. Baseline characteristics for roxadustat and placebo groups were comparable. Roxadustat 0.7, 1.0, 1.5, or 2.0 mg/kg, increased Hb levels in a dose-related manner. Hb responder rates were dose dependent and ranged from 30 percent with roxadustat 0.7 mg/kg to 100 percent with roxadustat 2 mg/kg. The median time to response ranged from 42 days (1 mg/kg) to 14 days (2 mg/kg). Roxadustat transiently and moderately increased endogenous erythropoietin and reduced hepcidin levels. Adverse events were similar in the roxadustat and placebo groups. Most common adverse events associated with roxadustat were diarrhea (9.1%), headache (6.8%), back pain (4.5%), fatigue (4.5%) and hyperkalemia (4.5%). Detailed results and safety data from the trial were published in Nephrology Dialysis Transplantation and can be viewed here

"FibroGen is committed to improving outcomes for people living with anemia of CKD and related conditions through the roxadustat program and the portfolio of HIF-PHI research we are building," said Tom Neff, chief executive officer of FibroGen. "We look forward to the future publication of our other completed Phase 2 studies of roxadustat, including those of dialysis and incident dialysis patients."

Through FibroGen's strategic collaborations with AstraZeneca AB and Astellas Pharma Inc., roxadustat is currently in global Phase 3 development.

About Roxadustat

Roxadustat (FG-4592) is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in development for the treatment of anemia in patients with chronic kidney disease (CKD). HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, "turning on" erythropoiesis (the process by which red blood cells are produced) and other protective pathways.

About FibroGen

FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases, or HIF-PHs, in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. For more information please visit:

CONTACT: Greg Mann
         FibroGen, Inc.