Keryx Biopharmaceuticals (Nasdaq: KERX) reported today the randomization of the last patient in its short-term study component of its Phase 3 registration program of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis. The Zerenex Phase 3 clinical program is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). The Company expects to complete the study and report top-line data before the end of the year.
The Zerenex Phase 3 short-term efficacy study is a multicenter, randomized, open-label clinical trial being conducted at 14 centers in the United States. Approximately 150 patients have completed the 2-week washout period and have been randomized 1:1:1 to receive a fixed dose of Zerenex (1 gram, 6 grams or 8 grams per day) for a treatment period of 28 days. The primary endpoint of the study is to demonstrate a dose response in the change of serum phosphorous from baseline (end of washout period) to end of the treatment period (day 28).
Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, and member of the Executive Committee of the Collaborative Study Group, is the Study Chair of the Zerenex Phase 3 registration program. Dr. Samuel S. Blumenthal, Professor of Medicine at Medical College of Wisconsin, is the study's Co-Principal Investigator.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are pleased by the rate of enrollment into this study, and we are grateful for the efficiency and dedication demonstrated by our clinical investigators. We look forward to announcing the top-line data from this study before year-end."
Concurrent with this short-term study component of the Phase 3 registration program, the Company is conducting its long-term (58-week) Phase 3 safety and efficacy study component for which enrollment is ongoing. Keryx expects to complete the Zerenex Phase 3 program and file a New Drug Application for Zerenex for the treatment of hyperphosphatemia in the first half of 2012.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
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