Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the “Company”) has announced results from a 48-week Open Label Extension (OLE) safety study in which Ferric Citrate demonstrated long-term safety and efficacy in dialysis-dependent chronic kidney disease (CKD) patients with elevated serum phosphorus levels, or hyperphosphatemia. The OLE findings were presented as a late-breaking poster (Abstract #SA-PO1102) at the 2014 American Society of Nephrology’s (ASN) Kidney Week meeting in Philadelphia, PA. The results are consistent with those seen in the pivotal Phase 3 trial.
Ferric Citrate, an iron-based phosphate binder, was approved by the U.S. Food and Drug Administration to control serum phosphorus levels in patients with CKD on dialysis in September 2014.
“The results presented at ASN provide further confirmation of Ferric Citrate’s potential in the dialysis setting,” said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. “Patients on dialysis take several medications to manage metabolic factors like elevated phosphate levels and iron deficiency that are common in end-stage renal disease. Having an iron-based phosphate binder with unique pharmacodynamic properties may be of clinical value to doctors treating patients in the dialysis setting.”
About the Ferric Citrate OLE Study Presented at ASN
The Ferric Citrate OLE study consisted of 168 patients who completed the pivotal 52-week, randomized, active control Phase 3 study. Of those enrolled, 166 patients were dosed with Ferric Citrate and 125 patients completed the OLE study lasting an additional 48 weeks. Over the 48-week OLE study period, patients received an average of 7.9 tablets a day. Ferric Citrate was administered as 1 gram tablets each containing 210 mg of ferric iron. The study was conducted in 35 U.S. sites. Safety in the study was assessed by recording and monitoring adverse events (AE), serious adverse events (SAE) and sequential laboratory data.
The OLE study demonstrated the AE profile of Ferric Citrate is similar to that seen in the long-term Phase 3 52-week active-control period, results of which were published in the July issue of the Journal of American Society of Nephrology. AEs occurred in 142 patients treated with Ferric Citrate and were primarily gastrointestinal-related, including diarrhea, nausea, vomiting and constipation. Serious adverse events occurred in 75 patients, though none were related to Ferric Citrate. In addition, there were no clinically or statistically significant differences in liver enzymes or aluminum levels observed.
* For Full Prescribing Information for Ferric Citrate, please visit http://www.keryx.com/wp-content/uploads/Keryx_FerricCitrate_PI.pdf.
Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients with renal disease. The Company’s lead product, Ferric Citrate, is approved in the United States for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx plans to commercially launch Ferric Citrate in the U.S. in December 2014. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
Keryx Biopharmaceuticals, Inc.