Keryx Biopharmaceuticals (NASDAQ:KERX) announced presentation of additional data from its pivotal Phase 3 study for iron deficiency anemia (IDA) and non-dialysis dependent chronic kidney disease (NDD-CKD) in four posters at the American Society of Nephrology’s 2016 Kidney Week taking place November 15-20 in Chicago. Data in the posters highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD. These results are a more detailed presentation of top line results announced in March 2016.
Ferric citrate (Auryxia®) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis.
Taken together, data in the posters demonstrate that in the Phase 3 trial, the majority of patients treated with ferric citrate, 52.1 percent (61/117), achieved the primary endpoint of ≥1 g/dL increase in hemoglobin at any point during the 16-week efficacy period, 93.4 percent (57/61) of whom had a sustained treatment effect. Increases in hemoglobin in ferric-citrate treated patients were observed as early as one to two weeks after the start of treatment. Efficacy results were consistent across groups with different baseline characteristics. These results were achieved without the concomitant use of erythropoietin-stimulating agents (ESAs) or intravenous (IV) iron. Adverse events were generally similar between treatment arms and consistent with the safety profile described in the U.S. prescribing information for Auryxia, with gastrointestinal (GI) disorders as the most common adverse event. Serum phosphorus levels stayed within target ranges for CKD.
“I’m pleased to have been involved in this pivotal Phase 3 study of ferric citrate,” said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center. “The data presented today at Kidney Week continue to underscore ferric citrate’s ability to increase iron stores and hemoglobin in patients with CKD and IDA, and support its potential utilization in non-dialysis dependent chronic kidney disease, if approved by the FDA for this indication.”
“People with chronic kidney disease suffer from a range of complications, including two that are very common, hyperphosphatemia and iron deficiency anemia,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “We are pleased to have the opportunity to further characterize the pivotal phase 3 trial results of ferric citrate’s investigational use in a scientific forum. These data support our goal to expand ferric citrate’s label and we look forward to submitting the sNDA for IDA in NDD-CKD patients to the FDA.” (Original Source)
Shares of Keryx Biopharmaceuticals are currently trading at $6.18, up $0.13 or 2.15%. KERX has a 1-year high of $7.80 and a 1-year low of $2.80. The stock’s 50-day moving average is $5.15 and its 200-day moving average is $5.53.
On the ratings front, Keryx Biopharmaceuticals has been the subject of a number of recent research reports. In a report issued on November 11, FBR analyst Christopher James reiterated a Hold rating on KERX, with a price target of $7, which represents a potential upside of 15% from where the stock is currently trading. Separately, on November 9, Maxim’s Jason Kolbert reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Jason Kolbert have a yearly average loss of 7.7% and 14.5% respectively. James has a success rate of 34% and is ranked #4024 out of 4226 analysts, while Kolbert has a success rate of 29% and is ranked #4125.
Keryx Biopharmaceuticals, Inc. engages in the development and commercialization of medicines for the treatment of renal disease. Its products include phosphate-binding medicines, intravenous iron, and other medications.