Yesterday, Keryx Biopharmaceuticals Inc. (KERX) announced positive long-term results from an open-label extension trial of its kidney drug, Zerenex. This oral, iron-based compound treats elevated serum phosphorous levels (hyperphosphatemia) in patients with end-stage renal disease (ESRD) on dialysis.
Results revealed that serum phosphorous was well-controlled under the drug’s effect. The mid-stage trial involved 29 patients in Taiwan who were followed for a year. Prior studies of the drug did not exceed 28 days.
The study also indicated that Zerenex could maintain phosphorus content at a normal level when used over an extended period of time. Additionally, signs of potential iron overload in the blood were not displayed. Zerenex is expected to enter a late-stage study at the end of the year.
As per data from the US Renal Data System, America has nearly 485,000 ESRD patients. This is projected to rise to about 785,000 by 2020. The majority of ESRD patients require dialysis.
The US market for phosphate binders to treat hyperphosphatemia in ESRD patients exceeded $600 million in 2008. It has registered an approximate growth of 25% per annum over the last five years.
The growing dialysis care market has hemodialysis as the most preferred method of treatment in this segment. The other mode of treatment peritoneal dialysis finds favor with a much lesser number of dialysis patients.
The acquisition of Renal Care Group by Fresenius Medical Care (FMS) and acquisition of Gambro by DaVita (DVA) has changed the competitive landscape of the dialysis industry. The two companies now dominate the dialysis services sector.
The positive news regarding Zerenex comes close on the heels of Keryx’s candidate KRX-0401 being granted orphan-drug status by the US Food and Drug Administration for the treatment of multiple myeloma. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the U.S., Canada and Mexico.
The news about the positive long-term data from Zerenex had a positive impact on Keryx’s share price, sending it to a new 52-week high of $3.33 on Wednesday morning. It however ended the day at $2.69 on Nasdaq.
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