Rockwell Medical (RMTI) Monday said, Soluble Ferric Pyrophosphate, or SPF, an investigational iron-delivery drug, met primary endpoint in the Phase 3 clinical studies for the treatment of iron deficiency in hemodialysis patients.
The primary endpoint of the randomized, double-blinded, multi-center study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery.
The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents during hemodialysis by 37.1 percent while maintaining iron balance and maximizing iron delivery.
The 11 microgram/dL SFP dose was found to deliver sufficient iron without increasing iron stores while greatly reducing ESA dose, with a safety profile similar to placebo.
A 37 percent higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period.
SFP's ability to substantially reduce ESA use in the treatment of anemia should translate into significant cost savings in dialysis care while potentially lowering the serious risks associated with the dosing of ESAs.
A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.
The upcoming efficacy results from the Phase 3 CRUISE studies are expected to read-out in the 2nd-half of 2013.
by RTT Staff Writer
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