Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate (SFP), a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.
During the meeting, Rockwell solicited input on the Company's planned Phase III clinical program for SFP. As a result of those conversations with the FDA, Rockwell has confirmed a change in hemoglobin is an approvable endpoint for the Phase III trial design. The Company will now use data from the prior Phase IIb study of SFP to finalize the Phase III protocol for FDA submission.
"Meeting with the FDA to review our Phase IIb data and solicit input for our planned Phase III program was an important corporate and clinical milestone," said Robert L. Chioini, Chairman, CEO and President of Rockwell. "The FDA provided clear and valuable feedback for our proposed Phase III program and we now have an acceptable endpoint for our Phase III trial design. We are incorporating the FDA's comments into a final protocol design, which will be submitted shortly, and we expect to remain on track to initiate the Phase III program later this year."
NIH grants $2.6 million to explore the effects of high blood-pressure drugs in CKD patients