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Promising Phase 2 Data Show Roxadustat Corrected Anemia in Chronic Kidney Disease Patients Before Intervention with Dialysis

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SAN FRANCISCO, April 20, 2016 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) ("FibroGen"), a research-based biopharmaceutical company, today announced that the Clinical Journal of the American Society of Nephrology has published promising results of a Phase 2 study for roxadustat, an investigational therapy for the treatment of anemia in patients with chronic kidney disease (CKD).

The published results show that roxadustat increased and maintained hemoglobin and decreased hepcidin levels in anemic CKD patients when administered using multiple dosing strategies, continuing to support the hypothesis that roxadustat enables coordinated erythropoiesis. These CKD patients received no previous treatment with erythropoiesis-stimulating agents, were not on dialysis, and were treated with roxadustat regardless of baseline iron repletion status.

Of the 143 patients evaluable for efficacy, 92% achieved a hemoglobin response defined as a hemoglobin increase of > 1.0 g/dl from baseline and hemoglobin of > 11.0 g/dl by the end of treatment (up to 16 weeks of treatment in 47 patients, and up to 24 weeks of treatment in 96 patients).

Generally, patients in all cohorts who received higher starting doses of roxadustat demonstrated earlier achievement of the hemoglobin response. Intravenous iron was not permitted throughout the study period although only 52.4% of study patients were iron-replete at baseline.  As has been shown in previously published results from Phase 2 studies, roxadustat increased hemoglobin independently of the patients' baseline iron repletion and inflammatory status as measured by baseline C–reactive protein levels.  Also consistent with previously seen results, treatment with roxadustat resulted in decreases in hepcidin and in total cholesterol levels: specifically, a decrease in hepcidin levels of 16.9% (P=0.004) and a decrease in total cholesterol levels by a mean (±SD) of 26 (±30) mg/dl (P<0.001) after 8 weeks of therapy.

"In this study, anemia correction was achieved under a range of treatment options including tiered weight as well as fixed-starting-dose strategies. Correction of anemia and maintenance of hemoglobin response were seen at different dose frequencies (two or three times weekly for achievement of hemoglobin response, one or two or three times weekly for maintenance)," said Robert Provenzano, M.D., lead author and chief of the Division of Nephrology, Hypertension & Transplantation, director of Nephrology Research, and director of Acute Dialysis Services at St. John Hospital and Medical Center in Detroit, Michigan. "Secondary analyses showing decreases in hepcidin and increased iron utilization, as well as reductions in total cholesterol levels, suggest roxadustat consistently affects these parameters."

"This study shows that roxadustat can successfully correct anemia in chronic kidney disease patients who are not yet receiving dialysis," said Thomas B. Neff, chief executive officer of FibroGen.  "In exploring different dosing regimens, these results show that roxadustat achieved and maintained hemoglobin response at various dose frequencies, and provide continued evidence of roxadustat's ability to achieve anemia correction without intravenous iron supplementation.  FibroGen and our partners are encouraged by these results as we continue to advance the roxadustat global Phase 3 program and hope to provide a safer and more accessible option for patients."

About the Study
In this randomized, open-label study, 145 patients with anemia (hemoglobin < 10.5 g/dl at baseline) and non-dialysis CKD were randomized into one of six cohorts of approximately 24 patients, each with varying roxadustat starting doses (tiered weight and fixed amounts) and frequencies (two and three times weekly), followed by hemoglobin maintenance with roxadustat one to three times weekly. Treatment duration was 16 or 24 weeks. Intravenous iron was prohibited. The primary end point was the proportion of patients achieving hemoglobin increase of > 1.0 g/dl from baseline and hemoglobin of > 11.0 g/dl by the end of treatment (up to 16 weeks of treatment in 48 patients, and up to 24 weeks of treatment in 97 patients). Secondary analyses included mean hemoglobin change from baseline, iron utilization, hepcidin and serum lipids. Safety was evaluated by frequency and severity of adverse events.

Roxadustat was well tolerated with no drug-related serious adverse events. Treatment-emergent adverse events were reported in 80 percent of all patients in the safety population. The most common adverse events that occurred in greater than 5 percent of patients on roxadustat were nausea, diarrhea, constipation, vomiting, peripheral edema, urinary tract infection, nasopharyngitis, sinusitis, dizziness, headache, and hypertension. The nature and severity of the adverse events were typical for patients with chronic kidney disease.

About Roxadustat (FG-4592)
Roxadustat is currently in Phase 3 development as a potential therapy for anemia associated with chronic kidney disease in both patients on dialysis and not on dialysis. Roxadustat is an orally administered small molecule inhibitor of hypoxia-­inducible factor (HIF) prolyl hydroxylase activity. 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.

AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat (FG-4592) for the treatment of anemia in patients with CKD in the U.S., China, and other markets. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat in Europe, Japan, the Commonwealth of Independent States, the Middle East, and Africa. 

For information about roxadustat studies that are currently recruiting patients, please visit clinicaltrials.gov at this link: https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search

About Chronic Kidney Disease
Chronic kidney disease (CKD) affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although the disease can occur at any age, it becomes more common in aging populations and its prevalence is increasing. Anemia is a common complication of CKD and is associated with significant morbidity and mortality in both the dialysis and non-dialysis populations. In addition, CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large and growing unmet medical need.  Currently, no curative treatment or ability to stop kidney deterioration in patients with CKD exists, with the exception of kidney transplantation.

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 (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 Duchenne muscular dystrophy (DMD).  For more information please visit: www.fibrogen.com.

Forward-Looking Statements
This release contains forward-looking statements, including statements regarding the tolerability of roxadustat, the potential ability of roxadustat to maintain anemia correction without ongoing intravenous iron repletion, the potential ability of roxadustat to maintain hemoglobin levels in multiple types of CKD patients being treated for anemia using multiple dosing strategies, and the potential for continued safety or efficacy in roxadustat Phase 3 studies.

Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

Contact: Leanne Price 415.978.1200 lprice@fibrogen.com

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