Keryx Biopharmaceuticals has announced results of the Open Label Extension (OLE) trial of Zerenex for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.
The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomised, multi-center, multi-national dose-ranging phase 2 study. The OLE was designed to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex phase 2 clinical trials did not exceed 28 days.
The OLE trial provided for a daily dose, ranging from 2 to 6g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging phase 2 study. The average duration of the patients participation in the OLE trial was 306 +/- 85 days.
Ron Bentsur, CEO of Keryx, said: “We are very excited about this long-term data for Zerenex. The study suggests that Zerenex can maintain patients within the normal serum phosphorous range for extended periods of time and that the drug appears to be well-tolerated. We are also very encouraged by the emerging data suggesting that Zerenex may reduce the need for IV iron or EPO in this dialysis patient population, and should the results be replicated in the upcoming phase 3 program, this could represent a significant clinical and cost advantage to the patient and the doctor.”