New Iron Therapy Successful in Reducing ESA Dosing

A novel iron supplement therapy under development at Rockwell Medical significantly reduced erythropoietin-stimulating agent (ESA) dosing by 37 percent over the course of a recent 9-month study. A randomized placebo-controlled phase II clinical trial demonstrated that the drug—soluble ferric pyrophosphate (SFP)—met the primary end point of lowering ESA use in patients with end stage renal disease (ESRD) receiving hemodialysis.

Unlike other iron supplement therapies, which are given intravenously, SFP is mixed into dialysate and administered during dialysis. SFP’s unique mechanism simulates the body’s delivery of dietary iron, which could contribute to its efficacy. Upon entering the bloodstream, the drug quickly binds to apotransferrin and travels to bone marrow.

The phase II PRIME trial involved 108 patients with ESRD receiving hemodialysis randomized to receive dialysate either with or without SFP. Hemoglobin levels in both the SFP and placebo groups were similar at the beginning and end of the trial. However, the ESA dosing needed to maintain hemoglobin levels was significantly lower in the SFP group. In addition, SFP maintained iron balance without increasing iron stores in other organs and had a safety profile similar to placebo.

“We believe that SFP’s unique ability to treat iron deficiency while dramatically reducing the need for ESA, without increasing iron stores, strengthens SFP’s potential to become the market leading iron therapy treatment for CKD-HD patients,” said Rockwell Medical President and CEO Robert Chioini. “SFP’s ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs.”

Based in Michigan, Rockwell Medical is currently conducting a phase III trial of SFP for use in the treatment of anemia in patients with ESRD who are receiving hemodialysis. At the trial’s conclusion, the company anticipates filing a new drug application with the U.S. Food and Drug Administration by the end of 2013.