Rockwell Reports Top-line Results From CRUISE-1 Phase 3 Study Of SFP

(RTTNews) - Rockwell Medical (RMTI) reported successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP. This 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.

SFP is the company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

The CRUISE-1 study 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. SFP also 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.