Phase III CRUISE-1 study of SFP (Rockwell Medical) meets primary endpoint for Iron Deficiency

The CRUISE-1 Phase III efficacy study of SFP (soluble ferric pyrophosphate), from Rockwell Medical, for the treatment of Iron Deficiency in chronic kidney disease patients receiving haemodialysis, has met its primary endpoint, demonstrating a statistically significant mean change in haemoglobin from baseline to End-of-Treatment. This long-term study is the first of two identical Phase III efficacy studies to provide clinical data required to file a New Drug Application (NDA) with the FDA.

The mean difference between SFP and placebo was 3.6 g/L in favor of SFP, and was statistically significant. 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.

At End-of-Treatment, the difference between groups was a statistically significant 2.1% difference in favor of SFP. Serum ferritin, a marker of tissue iron stores, declined by 14.7% from baseline in the SFP arm while the placebo group ferritin level declined by 28.2%. The adverse events reported were those that are expected in the chronic haemodialysis population.