Keryx Biopharmaceuticals (Nasdaq: KERX) today announced completion of patient enrollment in the long-term study component of its Phase 3 registration program of Zerenex™, the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The Zerenex Phase 3 registration program, which is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), is comprised of an already successfully-completed Phase 3 short-term study, and this ongoing Phase 3 long-term study.
This Phase 3 long-term study is a multicenter, randomized, open-label, safety and efficacy clinical trial in over 400 ESRD patients on hemodialysis or peritoneal dialysis. The study consists of a 2-week washout period followed by a 52-week safety assessment in which patients are randomized 2:1 to receive either Zerenex or an active control. The 52-week safety assessment period is followed by a 4-week efficacy assessment. During the 4-week efficacy assessment, only those patients randomized to treatment with Zerenex during the safety assessment period will be randomized in a 1:1 ratio to either continue treatment with Zerenex or to be switched to placebo for a 4-week period.
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 to have completed patient enrollment into the Zerenex Phase 3 long-term study, over-enrolling slightly to meet patient and physician interest in the study. We remain grateful to the investigators for their continued dedication and commitment to the clinical development of Zerenex."
In April 2011, the Company reported the positive final dataset from the Zerenex Phase 3 short-term study.
Keryx Biopharmaceuticals, Inc.