Positive results from Phase III trial of PA21 (Vifor Pharma) for controlling Hyperphosphataemia

The pivotal Phase III clinical study shows that PA21 (iron oxyhydroxide), from Vifor Pharma, successfully controls Hyperphosphataemia in patients with chronic Kidney Disease on dialysis. Results of the 6-month, study with more than 1,000 patients conducted in the USA, Europe as well as in Russia, Ukraine and South Africa established the superiority of maintenance doses of PA21 versus a PA21 inactive low-dose in sustaining the phosphate-lowering effect in dialysis patients. In addition, PA21 was shown to be as good as sevelamer carbonate, a current standard of therapy, in lowering serum phosphorus levels after 12 weeks of treatment, using an average of 3-4 tablets of PA21 per day (compared to 8-9 of sevelamer carbonate). PA21 appears to be generally well-tolerated and efficacious with the advantage of a lower pill burden.

The study met its primary and secondary endpoints, and will be used as the basis for regulatory filings in the USA, Europe and Switzerland. The current trial will be followed by a six-month safety extension study. Full results from the study will be submitted for presentation at the American Society of Nephrology (ASN) Kidney Week taking place in San Diego, California, from October 30 to November 4 2012. Results will also be submitted to peer review journals.