Phase III CRUISE 2 study of SFP success for Iron Deficiency
Rockwell Medical reported top-line results from the long-term CRUISE-2 Phase III 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 haemodialysis.
In this study, SFP met the primary endpoint, demonstrating a statistically significant mean change in haemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of haemoglobin, maintenance of reticulocyte haemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the second and final study of two identical Phase III efficacy studies to provide clinical data required for the Company to file a New Drug Application (NDA) with the FDA.
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