Keryx Biopharmaceuticals, Inc. (KERX) Begins Phase II Study of Zerenex for Treatment of Patients with Kidney Disease

Keryx Biopharmaceuticals is focused on medically important pharmaceutical products for the treatment of renal disease. The company is currently developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind phosphate and form non-absorbable complexes.

The company today announced the initiation of a Phase 2 study of Zerenex in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD). In the U.S. alone, over 1.5 million people suffering from Stages 3-5 NDD-CKD have iron deficiency anemia. However, there are currently no oral iron supplements with an FDA label nor are there any FDA-approved phosphate binders.

The Phase 2 study started today is a multi-center, randomized, safety and efficacy clinical trial designed to compare the ability of Zerenex to manage serum phosphorus and iron deficiency versus placebo in anemic patients with Stages 3 to 5 NDD-CKD. The study plans to randomize about 150 patients in approximately 15 sites in the U.S.

Eligible patients will be randomized 1:1 to receive either Zerenex or placebo for a 12-week treatment period. The primary endpoints of the study are to demonstrate changes in ferritin, TSAT, and serum phosphorus levels over the 12-week treatment period. Secondary endpoints of the study include changes in hemoglobin and FGF-23. Study completion is expected sometime in mid-2013.

Zerenex is also in a long-term Phase 3 study, under Special Protocol Assessment, as a treatment for end-stage renal disease patients with hyperphosphatemia on dialysis. Top-line data from this study is expected to be announced around year-end. The NDA filing is expected to occur in the first quarter of 2013 for this indication.

For further information about Keryx Biopharmaceuticals and its Zerenex product, please visit www.keryx.com

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