(By Balaseshan) Keryx Biopharmaceuticals (NASDAQ: KERX) said it has initiated a phase 2 study of Zerenex (ferric citrate) for the treatment of patients with stage 3 to 5 non-dialysis dependent chronic kidney disease (NDD-CKD).
Zerenex is the company's ferric iron-based phosphate binder drug candidate for managing serum phosphorus and iron deficiency in anemic patients with NDD-CKD.
In the United States alone, over one and a half million people suffering from Stages 3 to 5 NDD-CKD have iron deficiency anemia, however, there are currently no oral iron supplements with an FDA label in NDD-CKD. Also, there are currently no FDA approved phosphate binders in NDD-CKD.
The phase 2 study initiated today is a multicenter, randomized, safety and efficacy clinical trial designed to compare the ability of Zerenex to manage serum phosphorus and iron deficiency versus placebo in anemic patients with stages 3 to 5 NDD-CKD. Eligible patients will be randomized 1:1 to receive either Zerenex or placebo for a 12-week treatment period.
The primary endpoints of the study are to demonstrate changes in ferritin, TSAT and serum phosphorus levels over the 12-week treatment period. Secondary endpoints include changes in hemoglobin and FGF-23.
The study plans to randomize about 150 patients from about 15 sites in the U.S. Patient enrollment is expected to take up to 6 months, with study completion expected in mid-2013.
Zerenex is currently also in a long-term phase 3 study, under special protocol assessment, as treatment for end-stage renal disease patients with hyperphosphatemia on dialysis. Top-line data from this Phase 3 study is expected to be announced by approximately year-end 2012, with the NDA filing expected in the first quarter of 2013 for this indication.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech Inc. The company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
It is estimated that about 10 percent to 15 percent of the U.S. adult population is affected by chronic kidney disease (CKD), a condition generally characterized by greater than 50 percent reduction of normal kidney function. In addition, elevated levels of serum phosphorus become more prevalent in stages 3 to 5 non-dialysis dependent CKD (NDD-CKD) patients.
Several studies have shown that higher serum phosphorus concentrations may be associated with increased mortality and morbidity in CKD, however, no phosphate binders are currently FDA approved for NDD-CKD.
KERX is trading down 0.80 percent at $2.47 on Thursday. The stock has been trading between $1.28 and $5.19 for the past 52 weeks.