Rockwell Medical Inc. said its investigational iron-replacement drug Triferic, previously known as Soluble Ferric Pyrophosphate (SFP), has received positive results in a study designed to test its safety. The study was performed as part of the company's new drug application for Triferic, which is indicated for chronic kidney disease patients receiving dialysis.
"We are very pleased with the results of the short-term safety study," said Rob Chioini, CEO of Rockwell. "Triferic's clean safety profile together with its unique mode of action enabling efficient iron delivery and hemoglobin maintenance, while significantly reducing the need for ESA, highlight its potential to be the market-leading iron therapy treatment for CKD-HD patients."
This safety study was a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, Phase 3 study with an enrollment of 718 CKD-HD patients in the United States and Canada. It is followed by an ongoing optional open-label, uncontrolled extension study. Rockwell said this study demonstrated that:
- Triferic reliably delivers iron via dialysate.
- There were no specific adverse events directly attributable to Triferic
- The adverse events during Triferic administration were those common in CKD-HD patients.
- No difference in type, frequency, severity or resolution of adverse events between Triferic and placebo.
- No anaphylaxis or hypersensitivity attributable to Triferic
- No evidence of changes in hepatic enzymes between Triferic and placebo.
- No evidence of first use events or an increase in hypotension.