Zerenex (Keryx Biopharma) success in Phase II trial for NDD-CKD

Keryx Biopharmaceuticals, Inc. announced successful top-line results from its Phase II study of Zerenex (ferric citrate coordination complex) in non-dialysis dependent Chronic Kidney Disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anaemia. In this study, Zerenex met both co-primary endpoints, demonstrating highly statistically significant changes in serum phosphorus and transferrin saturation (TSAT) versus placebo over the 12-week treatment period. In addition, Zerenex met the key secondary endpoints of increasing ferritin and hemoglobin, and decreasing fibroblast growth factor-23 (FGF-23) versus placebo. The Company plans to meet with the Food and Drug Administration (FDA) to discuss these data with the goal of defining a path forward towards obtaining a labelled indication for the treatment of iron deficiency anaemia in NDD-CKD patients.