We are advancing roxadustat, our first-in-class, oral small molecule for treatment of anemia associated with chronic kidney disease (CKD), through global Phase 3 clinical development.
Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes coordinated erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin. Administration of roxadustat has been shown to increase red blood cell production while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation, and without a need for supplemental intravenous iron.
With our partners, AstraZeneca and Astellas, we are pursuing a global product development program encompassing a total of fifteen Phase 3 studies, with target enrollment of an estimated 10,000 patients worldwide, to support independent regulatory approvals of roxadustat in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients in the U.S., Europe, Japan, and China. The roxadustat Phase 3 clinical program follows extensive completed Phase 1 and Phase 2 clinical trials (with more than 1400 patients) that demonstrated correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. Further, in the two Phase 3 registrational trials conducted in China, roxadustat was shown to meet primary efficacy endpoints in both DD-CKD and NDD-CKD patients. These trials will support the filing of our new drug application to the China Food and Drug Administration (CFDA) in 2017.
Roxadustat is also entering a Phase 3 clinical trial in the U.S. and a Phase 2/3 clinical trial in China for a second indication in anemia associated with myelodysplastic syndrome (MDS). Clinical trials are expected to initiate in the second half of 2017.
Additional information about roxadustat trials currently recruiting patients can be found at: www.ClinicalTrials.gov.