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.

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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.

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"We expect CRUISE-2 top-line results to confirm the positive CRUISE-1 results that were announced a couple weeks ago."

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.

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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.