Anemia
FibroGen is developing orally active HIF-PHI for treatment of anemia and is the first company to demonstrate proof of principle for oral anemia therapy in human clinical studies. FibroGen believes there are many potential advantages of HIF-PHI over erythropoiesis stimulating agents (ESAs) currently used to treat anemia and that significant opportunity exists to expand the market for anemia therapy with HIF-PHI.
HIF-MEDIATED ERYTHROPOIESIS
HIF-PHIs work through an entirely different mechanism of action than ESAs do. HIF-PHIs stabilize HIF, the key regulatory protein that coordinates all elements of erythropoiesis necessary for proper formation of mature red blood cells plump with iron-rich, oxygen-carrying hemoglobin molecules. HIF also down-regulates hepcidin, a regulatory hormone that limits iron availability and thus suppresses erythropoiesis under conditions of inflammation. Read more
GENETIC PROOF OF CONCEPT FOR SELECTIVE ERYTHROPOIESIS
The safety of long-term HIF activation is supported by examples from medicine and nature, such as congenital polycythemia (too many red blood cells), which is a disorder that can be caused by genetic mutations in the oxygen-sensing system leading to chronic HIF activation. Read more
POTENTIAL CLINICAL BENEFITS OF HIF-PHI THERAPY FOR ANEMIA
Available data suggests that HIF-PHI may offer several safety and efficacy advantages over current ESA therapy including correction of anemia with normal physiological levels of erythropoietin and correction of anemia without increasing blood pressure and treatment of dialysis patients who are hyporesponsive to ESAs. Read more
ANEMIA MARKETS
Although ESAs were introduced nearly two decades ago, the chronic kidney disease anemia market in the US is still limited to treatment of dialysis patients. Oral bioavailability of HIF-PHI may increase access to anemia therapy for the largely underserved population of patients with anemia of chronic kidney disease who are not yet on dialysis and has the potential to successfully treat ESA-hyporesponsive dialysis patients. Read more
ANEMIA CLINICAL STUDIES
FG-2216 and FG-4592, FibroGen’s first two erythropoietic HIF-PHI, have been the subject of clinical studies involving nearly 700 subjects. Proof of principle has been demonstrated in dialysis and non-dialysis settings of anemia associated with chronic kidney disease, and both investigational drugs have been found generally safe and well tolerated in clinical studies conducted to date. Read more
DISCOVERY RESEARCH
In addition to clinical development, FibroGen has a research program to further exploit certain beneficial properties resulting from the stabilization of HIF. New classes of compounds have been identified, which are considerably more potent for endogenous erythropoietin up-regulation than compounds currently in development. FibroGen expects to advance one or more of these compounds to clinical trials in the near future. Read more
