Rockwell Medical announces SFP meets endpoints in Phase 3 study

Rockwell Medical announced successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP. SFP is the company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In the Phase 3 efficacy study, SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the first of two identical Phase 3 efficacy studies to provide clinical data required for the company to file a New Drug Application with the U.S. FDA.