Rockwell Medical Reports Positive Top-line Results From Phase 3 CRUISE-2 Trial

(RTTNews) - Rockwell Medical (RMTI) announced successful top-line results from the long-term CRUISE-2 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. SFP met the primary endpoint in this trial, showing a statistically significant mean change in hemoglobin from baseline to End-of-Treatment.

Furthermore, SFP acheived the key secondary endpoints, such as the maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term trial is the second and final study of two identical Phase 3 efficacy studies to provide clinical data required for the company to file a New Drug Application or NDA with the U.S. FDA.

The CRUISE-2 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. The mean difference between SFP and placebo was 3.6 g/L in favor of SFP, and was statistically significant. Overall, the adverse events reported were consistent with what are expected in the chronic hemodialysis population.

This trial's primary outcome measure was the mean change in hemoglobin level from baseline to the End-of-Treatment. End-of-Treatment was defined as the average of the hemoglobin levels during the last 1/6th of the time each patient was in the randomized treatment period.