Biopharmaceutical company Shire Plc (SHPGY, SHP.L) announced Wednesday the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, Fosrenol and sevelamer hydrochloride in chronic kidney disease or CKD patients on haemodialysis.
CKD, also known as chronic renal disease, is a progressive loss of renal function over a period of months or years. There is no specific treatment unequivocally shown to slow the worsening of this disease. According to National Kidney Foundation, 26 million American adults suffer from CKD.
Fosrenol is approved by the U.S. FDA and also in the EU and Sweden to reduce serum phosphorus in patients with end stage renal disease. Fosrenol or lanthanum carbonate binds to dietary phosphate, preventing phosphate from being absorbed by the intestine.
The study was a 12-week, randomized, open-label crossover study, enrolling 182 patients across U.S., Puerto Rico, Germany and the UK. Patients were randomized to receive either Fosrenol or sevelamer hydrochloride (Genzyme's Renagel), and on completion of 4 weeks' treatment, they were switched to the alternative phosphate binder for a further 4 weeks.
In statistical analysis, the safety population was defined as all patients who took at least one dose of Fosrenol or sevelamer. The intention to treat, or ITT, population included all patients who had received at least one dose of either study drug and had at least one valid post-dose serum phosphorus measurement. The completer population was defined as all patients who completed 4 weeks of treatment on both study drugs and had a valid serum phosphorus measurement at week 4 of each treatment period.
The study's primary endpoint, change in serum phosphorus from baseline to end of treatment, was evaluated in the primary analysis using last observation carried forward, or LOCF, for the ITT population.
Shire noted that the analysis of LOCF for the ITT population did not reach statistical significance. However, in the completer population, the study showed that Fosrenol reduced serum phosphorus better than sevelamer, a statistically significant difference. A statistically significant difference was also observed between the treatments at week 1.
Study investigators concluded that the statistically larger reduction within the completer group suggested that Fosrenol may offer greater serum phosphorus reduction in CKD patients on haemodialysis.
Prof. Stuart Sprague of Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA, also a lead investigator commented, "This study is important, because up until now, there was no data comparing the relative efficacies of lanthanum carbonate and sevelamer. The findings suggest that over four weeks of treatment, FOSRENOL may be a more effective binder of phosphate. Further research is now required to evaluate whether the trends observed in this crossover study are continued in the long term."
Tuesday, SHPGY closed regular trading at $49.93, on the Nasdaq.
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