(FGEN) to Present Roxadustat Clinical Data
SAN FRANCISCO, Nov. 03, 2015 — FibroGen, Inc. (NASDAQ:FGEN) (“FibroGen”), today announced that analyses of clinical data from Phase 2 clinical trials of roxadustat (FG‑4592), a potential first-in-class oral compound in late-stage development for the treatment of anemia associated with chronic kidney disease (CKD), will be presented at the American Society of Nephrology (ASN) Kidney Week on November 5, 2015.
Roxadustat is currently in Phase 3 development as a potential therapy for anemia of chronic kidney disease both in patients on dialysis and in patients not on dialysis. The global development program is being conducted by FibroGen and its development partners, AstraZeneca and Astellas.
The schedule and details for the presentations are as follows:
- Anemia Correction with Roxadustat Lowers Hepcidin in Chronic Kidney Disease (both CKD and ESRD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO646 (Szczech, et al.)
- Anemia Correction with Roxadustat Increases Soluble Transferrin Receptor in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO647 (Szczech, et al.)
- Anemia Correction with Roxadustat Lowers Cholesterol in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO648 (Szczech, et al.)
- Anemia Correction with Roxadustat Improves Health Related Quality of Life (HRQOL) in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: Clinical Trials in CKD: Pursuing a New Horizon
Thursday, November 5, 2015, 6:06 PM PT
Oral Program # TH-OR039 (Szczech, et al.)
About Chronic Kidney Disease
CKD affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although it can occur at any age, it becomes more common in aging populations and its prevalence is increasing. Kidney disease can have multiple causes such as diabetes mellitus and hypertension. While there are treatments for many causes of kidney disease, there are currently no treatments that are curative or that can completely halt the loss of kidney function in CKD, creating a significant unmet medical need.
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 of chronic kidney disease both in patients on dialysis and in patients not on dialysis. Hypoxia-inducible factor is a 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. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate multiple programs targeting various therapeutic areas. Our 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 chronic kidney disease (CKD). Our 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 about FibroGen, please visit www.fibrogen.com.
Contact Greg Mann FibroGen, Inc. (415) 978-1433 gmann@fibrogen.com
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