Biopharmaceutical company Rockwell Medical has announced completion of patient dosing in its second Phase III efficacy study, called CRUISE-2, for soluble ferric pyrophosphate (SFP), an investigational iron-delivery drug.
The CRUISE-2 is the final Phase III study for SFP, which has been developed to treat iron deficiency in chronic kidney disease patients receiving haemodialysis.
Rockwell Medical founder, chairman and CEO Rob Chioini said the completion of the CRUISE-2 Phase III study marks the closing of Phase III efficacy trials.
"We expect CRUISE-2 top-line results to confirm the positive CRUISE-1 results that were announced a couple weeks ago," Chioini said.
The two Phase III studies, CRUISE-1 and CRUISE-2, are designed to demonstrate efficacy and safety of SFP-iron, delivered through dialysate, in adult CKD patients requiring haemodialysis.
In each of the prospective, placebo-controlled, multicentre studies, around 300 patients were enrolled and randomised equally between SFP and placebo groups for a 12-month treatment period.
The primary efficacy end-point of both the studies is the mean change in haemoglobin from baseline.
Rockwell Medical chief medical officer Dr Ray Pratt said: "SFP demonstrated a statistically significant difference in haemoglobin levels between patients receiving SFP and placebo in CRUISE-1, while showing a very clean safety profile, and we expect CRUISE-2 to do the same."
In CRUISE-1 Phase III efficacy study, SFP achieved the primary endpoint by demonstrating a statistically significant mean change in haemoglobin from baseline to end-of-treatment.
Key secondary endpoints such as maintenance of haemoglobin and reticulocyte haemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin were also met.
The company expects top-line results from CRUISE-2 in September, and plans to submit new drug application around four to six months later.