PA21: Pivotal phase III study met primary and secondary endpoints
Preparations for regulatory filings are under way
Monday, 9 July 2012,
The pivotal phase III clinical study shows that the new phosphate binder PA21 successfully controls hyperphosphatemia in patients with chronic kidney disease on dialysis. The study investigated the use of PA21 (iron(III)-oxyhydroxide) in treating hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis. The study met its primary and secondary endpoints, and will be used as the basis for regulatory filings in the USA, Europe and Switzerland.
_PA21 is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, starch and sucrose. 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.
_Hyperphosphatemia, the accumulation of phosphorus in the blood, is a common and serious condition in patients with CKD, particularly those requiring dialysis. While all dialysis patients are treated with phosphate binders, less than 50% achieve and maintain their target serum phosphorus levels. Hyperphosphatemia is a risk factor for CKD complications such as cardiovascular disease, secondary hyperparathyroidism and renal bone disease.
_Results will be used as the basis for regulatory filings in the USA, Europe and Switzerland. First submission is planned for fourth quarter of 2012.
_Full results from the phase III 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.
_Galenica is a diversified Group active throughout the health care market which, among other things, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. The Galenica Group enjoys a leading position in all its business sectors – Vifor Pharma, Logistics and Retail. A large part of the Group's income is generated by international operations.
_PA21 is a chewable, iron-based phosphate binder containing a mixture of polynuclear iron(III)-oxyhydroxide, starch and sucrose. Each tablet of PA21 contains the equivalent of 500mg of insoluble elemental iron. When taken with meals, PA21 adsorbs the dietary phosphate in the gastrointestinal tract, preventing its uptake into the blood. The phosphate bound to PA21 is subsequently eliminated through the faeces.
_PA21's prior Phase II clinical trial met both its primary and secondary endpoints. The serum phosphorus lowering efficacy of the two lowest active doses was numerically comparable to 4.8g/day sevelamer hydrochloride. PA21 was also well tolerated, with a comparable overall safety and tolerability profile.
_The recently completed Phase III trial was an open-label, randomised, active controlled, parallel group study to investigate the safety and efficacy of PA21 compared to sevelamer carbonate, followed by a randomized comparison of PA21 maintenance dose versus PA21 inactive low-dose in dialysis patients with hyperphosphatemia. It is followed by a six-month safety extension study.
_PA21 is developed in collaboration with Fresenius Medical Care (www.fmc-ag.com). It is also currently undergoing Phase II clinical development in Japan by Kissei Pharmaceuticals Co., Ltd.