Rockwell Medical SFP Meets Primary and Key Secondary Endpoints in Phase 3 CRUISE-1 Efficacy Study

Rockwell Medical

today 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 (NDA) with the U.S. FDA. The CRUISE-1 study successfully met its pre-defined primary efficacy endpoint, which was a change in hemoglobin from Baseline to End-of-Treatment between the SFP and placebo groups. The mean difference between SFP and placebo was 3.6 g/L (95% CI 0.8, 6.3) in favor of SFP, and was statistically significant (p=0.011). At baseline the two groups had similar hemoglobin levels (109.6 g/L SFP and 109.0 g/L placebo). The mean adjusted change from baseline hemoglobin to the end of the randomized treatment period in the SFP group was 0.6 g/L (95% CI -1.7, 2.8). In the placebo group there was a statistically significant decline of -3.0 g/L (95% CI -5.3, -0.8).