Nabi Biopharmaceuticals has commenced its PhosLo (calcium acetate) EPICK study in Chronic Kidney Disease (CKD) patients suffering from Stage 4 kidney disease.

The study is designed to demonstrate that PhosLo is effective and safe in controlling elevated phosphorus levels (hyperphosphatemia) in Stage 4 CKD patients without causing very low calcium levels (hypocalcemia), or high levels of acidity in the blood (metabolic acidosis). Results from the EPICK study will be used to support license applications in the United States and the European Union for the use of PhosLo in these pre-dialysis patients.

PhosLo is a prescription phosphate binder currently indicated for the control of hyperphosphatemia in patients with end- stage renal (kidney) disease (ESRD). The company currently markets PhosLo in the United States and has filed a Marketing Authorization Application (MAA) to market the product in Europe for the ESRD indication.

Stage 4 CKD is an increasing global healthcare challenge with over 400,000 patients in the US alone. Those patients are expected to progress to Stage 5 (requiring dialysis). The CKD patient population is expected to grow significantly, partly due to the general aging of the population and partly due to dramatic increases in factors such as hypertension, diabetes and obesity.