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news.Rockwell Medical is expected to present new data on its late-stage investigational drug Soluble Ferric Pyrophosphate(SFP), which is being studied for the treatment of iron-deficiency anemia in end-stage renal disease (ESRD) patients.
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Rockwell’s data from the company’s Phase IIb dose ranging clinical trial demonstrated a 13% dose reduction in ESA and 0.79g/dL increase in hemoglobin compared to placebo in the intermediate therapeutic dose groups of 12 and 10ug iron per dL respectively.
The data revealed that the placebo group did not show a significant decline in Hgb despite iron withholding, suggesting that prior IV-iron therapy had resulted in excess iron stores.
Rockwell chief scientific officer Ajay Gupta said that the study data on ESA-sparing with concomitant increase in hemoglobin provides important information about SFP and it’s mode of action once it enters the bloodstream via the dialysate.
"By transferring iron rapidly and directly to apo-transferrin, SFP appears to overcome inflammatory reticuloendothelial block thereby delivering iron directly to the bone marrow for hemoglobin generation and enhancing ESA responsiveness," Gupta said.
Harvard Medical School Medicine associate professor Ajay Singh said that the clinical trial data may call into question the therapeutic strategy of liberalising IV iron administration and targeting higher serum ferritin levels in an effort to reduce ESA utilisation, as it may further aggravate the state of iron overload.