Keryx Biopharmaceuticals announces positive Phase III study results for anaemia treatment
Keryx Biopharmaceuticals (NASDAQ: KERX) has announced positive top-line results for its Phase III study of ferric citrate for the treatment of iron deficiency anaemia (IDA) in adults with non-dialysis dependent chronic kidney disease.
The oral, iron-based medicine met its primary endpoint and all pre-specified secondary endpoints with statistical significance. The primary endpoint – proportion of patients achieving an increase in haemoglobin of greater than, or equal to, 1.0 g/dL during the efficacy period – achieved sufficiently positive results, which were significantly higher than those receiving the placebo (52.1% compared to 19.1%)
It is estimated that 1.6 million people in the US suffer with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anaemia. If approved by the FDA, it will be the only such iron treatment in tablet form available to these patients.
John Neylan, chief medical officer at Keryx Biopharmaceuticals, comments: “These Phase III results demonstrate that ferric citrate can effectively raise haemoglobin levels in stage 3-5 non-dialysis dependent chronic kidney disease patients, with effects observed as early as two weeks post-treatment initiation.
“Based on these results, we plan to submit an sNDA to the FDA in the third quarter, seeking to expand the label for ferric citrate to include the treatment of iron deficiency anaemia in people with stage 3-5 NDD CKD. We believe that the ability to treat iron deficiency anaemia, managing haemoglobin and iron levels, could have an important effect on the way kidney specialists treat these patients.”
Early indications on the stock market showed that Keryx was trading heavily in pre-market trading, with this positive study having the potential to send their stock soaring, according to industry analysts.
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