Zerenex meets endpoints in PERFECTED study for treatment of Hyperphosphatemia - Keryx Biopharma

Keryx Biopharmaceuticals, Inc. announced the publication of results from the long-term, randomized, active control Phase III study of Zerenex (ferric citrate), the Company's investigational oral ferric iron-based phosphate binder, for the treatment of Hyperphosphatemia in patients with End-Stage Renal Disease (ESRD) on dialysis. The PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) was published online in the Journal of the American Society of Nephrology (JASN).

This Phase III study was a multicenter, randomized, open-label trial in 441 ESRD patients on hemodialysis or peritoneal dialysis designed to determine the safety and efficacy of Zerenex as a treatment to reduce serum phosphorus as well as raise iron stores and reduce intravenous (IV) iron and erythropoietin-stimulating agents (ESA) usage. Zerenex met the study's primary end-point demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Placebo Control Period. Using a sequential gatekeeping strategy for the key pre-defined secondary end-points, Zerenex also demonstrated statistically significant increases in serum ferritin and transferrin saturation (TSAT), and significant reductions in the use of IV iron and ESAs, versus an active control of Renvela (sevelamer carbonate) and/or Phoslo (calcium acetate) over the 52-week Active Control Period of the study. In addition, mean hemoglobin levels were higher in subjects treated with Zerenex as compared to subjects treated with active control.

The Company's New Drug Application (NDA) is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of September 7, 2014.

See-"Ferric Citrate Controls Phosphorus and Delivers Iron in Patients on Dialysis"- Julia B. Lewis, Mohammed Sika, Mark J. Koury, Peale Chuang, Gerald Schulman, et al., for the Collaborative Study Group -JASN ASN.2014020212; published ahead of print July 24, 2014, doi:10.1681/ASN.2014020212.