FibroGen to Present Phase 2 Data for FG-4592, An Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI), at American Society of Nephrology (ASN) Kidney Week 2012
FibroGen, Inc., today announced that two abstracts relating to FG-4592, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) clinical candidate for the treatment of anemia in chronic kidney disease, have been accepted for oral and poster presentations at the American Society of Nephrology (ASN) Kidney Week 2012. The annual meeting will be held October 30 – November 4, 2012, in San Diego, California. Full abstracts can be viewed online at http://www.asn-online.org/education/kidneyweek/archives/.
The schedule and details for the FG-4592 oral and poster presentations at ASN are as follows:
FG-4592, an Oral Hypoxia-Inducible Factor Prolyl Hydroxylase
Inhibitor, Corrects Anemia Without Iron Supplementation in Incident
Thursday, November 1, 2012, 4:30 p.m. – 6:30 p.m.
Oral Program # TH-OR096 (Besarab, et al).
FG-4592, a Novel Oral Hypoxia-Inducible Factor Prolyl Hydroxylase
Inhibitor (HIF-PHI), Maintains Hemoglobin Levels and Lowers
Cholesterol in Hemodialysis (HD) Patients: Phase 2 Comparison with
Friday, November 2, 2012, 10:00 a.m. – 12:00 p.m.
Poster Board # FR-PO257 (Provenzano, et al).
About Anemia of Chronic Kidney Disease (CKD)
CKD is a worldwide critical healthcare problem that affects millions of people and drives significant healthcare cost. In the U.S., prevalence of CKD has increased dramatically in the past 20 years, from 10% of the U.S. adult population (or approximately 20 million U.S. adults) per the National Health and Nutrition Evaluation Survey (NHANES) 1988-1994, to 15% (or approximately 30 million adults) in NHANES 2003-2006. In 2009, total Medicare costs for CKD patients were $34 billion.
Anemia is the condition of having fewer red blood cells and/or lower hemoglobin levels than is normal. The prevalence of anemia increases with the progression of CKD and is a demonstrated risk multiplier in patients with preexisting cardiovascular disease. Anemia has been associated with adverse outcomes in CKD patients, increased hospitalization rates, increased mortality, and reduced quality of life, but the condition tends to be undertreated due in part to the cost and complexity of treatment with injectable erythropoiesis-stimulating agents (ESAs) and intravenous iron supplements. Whereas nearly all patients on hemodialysis have easy access to ESA therapy, only 2% of CKD patients receive treatment with ESAs prior to referral to a nephrologist in the U.S.1 Under-treatment of anemia in the primary care setting can be attributed in part to lack of convenience and reimbursement rules, requiring physicians to buy ESA inventory and bill after procedures. This deters physicians in the primary care setting where anemic patients are a minority of total patients. The company estimates there are 1 million late-stage CKD patients (CKD Stages 3-5) with anemia in the U.S., and less than 20% are treated with ESAs prior to initiation of dialysis.1
FibroGen is developing FG-4592, a novel oral HIF-PHI, for the treatment of anemia in patients with CKD. FG-4592 has been shown to correct and maintain hemoglobin levels in patients with CKD not receiving dialysis2 and in patients with end-stage renal disease receiving dialysis3 without the need for supplementation with intravenous iron. An Independent Data Monitoring Committee has found no signals or trends to date to suggest that treatment with FG-4592 is associated with increased risk of cardiovascular events, thrombosis, or increases in blood pressure requiring initiation or intensification of antihypertensive medications.
Global Development of FG-4592
FG-4592 is in clinical development in the U.S., Europe, Japan, and the People's Republic of China. Multiple clinical trials in the U.S. have progressed toward commencement of Phase 3 clinical development in the U.S. and Europe by the end of 2012. In Japan, Astellas has completed Phase 1 studies and plans to begin Phase 2 studies soon. On September 20, 2010, FibroGen announced that the Chinese State Food and Drug Administration had granted FibroGen a clinical trial application approval to commence Phase 1 and Phase 2 clinical development for FG-4592 for the treatment of anemia associated with CKD in the People's Republic of China. Phase 1 in China is completed, and FibroGen has completed dosing in all patients in two Phase 2 studies in CKD anemia, in patients on dialysis and in patients not on dialysis. Phase 3 clinical development in China is expected to commence in 2013.
Astellas has licensed certain rights from FibroGen to FG-4592 (Astellas designation ASP1517) in Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. As part of these agreements, Astellas pays 50% of development costs for FG-4592 in the U.S. and Europe, and makes milestone payments for clinical advancement and approvals in Europe and in Japan, as well as other subsequent events. FibroGen retains rights to its anemia therapies in North America and South America, remaining parts of Africa, and all of Asia Pacific ex-Japan.
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.
1. U.S. Renal Data System, USRDS 2012 Annual Data Report: Atlas of Chronic Kidney and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2012
2. Besarab A, et al (2011) J Am Soc Nephrol 22:196A
3. Provenzano R, et al. (2011) Am. J. Kidney Dis Vol. 57 4:B80
Meichiel Keenan, 415-978-1431