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Phosmin

Phosmin is a non-aluminum, calcium-based phosphate binder 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.

Calcium acetate is an effective intestinal, calcium-based phosphate binder. When taken with meals, calcium acetate combines with dietary phosphate to form insoluble calcium phosphate, which is subsequently excreted in the feces. It can control phosphorus absorption from the gastrointestinal tract, and thereby controls the serum phosphorus level.

Patients with higher-than-normal serum calcium levels should be closely monitored and their dose adjusted to bring levels to normal. For those dialysis patients who are clinically hypercalcemic, with severe vascular and/or other soft tissue calcifications, PUMC Pharmaceutical is also developing FC818, a non-aluminum and non-calcium phosphate binder.

Development Status of Phosmin

PUMC Pharmaceutical is developing Phosmin, a calcium acetate product for binding phosphate in dialysis patients with ESRD. Phosmin is currently in preclinical development.

*Institute of Southern Medical Economics, March 2009