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FC818

FC818 is a novel non-aluminum, non-calcium phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

Hyperphosphatemia in ESRD Patients

In China, the prevalence of CKD is approximately 9.3%*. From 2001 to 2006, patients undergoing hemodialysis, peritoneal dialysis and renal transplantation increased at a rate of 11% per year.

In China, there are more than 60,000 patients with end-stage renal failure (ESRD), with limited or no kidney function. In these patients, phosphate retention and the resulting hyperphosphatemia are usually associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and the progression of renal failure – all of which significantly increase patient mortality and morbidity.

As such, phosphorus control is critical to the quality of care for dialysis patients.

Treatment with Phosphate Binders

The treatment of hyperphosphatemia usually involves dialysis in conjunction with dietary phosphate restrictions and intake of phosphate binders. Phosphate binders are generally classified as aluminum-based, calcium-based and non-calcium-based drugs. However, aluminum-based phosphate binders present unacceptable levels of associated toxicity in bone, brain and nerve tissues. As such, calcium and non-calcium phosphate binders now constitute the main treatment options globally.

 
Clinical Demand for Non-Calcium Phosphate Binders

Calcium-based phosphate binders, including PUMC Pharmaceutical’s Phosmin, are proven and effective agents for controlling serum phosphorous levels. However, these drugs can potentially promote a positive net calcium balance. Therefore, for hypercalcemic dialysis patients with severe vascular and/or other soft tissue calcifications, there is a clinical demand for a novel non-aluminum and non-calcium phosphate binder.

There are currently no non-calcium phosphate binders available for treating ESRD patients with hyperphosphatemia in China.

Development Status of FC818

PUMC Pharmaceutical is developing FC818, a novel non-aluminum, non-calcium phosphate binder.

One Phase I and two pivotal Phase II clinical trials showed FC818 to be an effective and safe treatment for lowering and/or maintaining serum phosphorus levels <5.5 mg/dL in ESRD patients with hyperphosphatemia. Based on these results, PUMC Pharmaceutical plans to initiate a pivotal Phase III clinical trial, to be completed in 2Q 2011.

*Institute of Southern Medical Economics, March 2009