Genzyme Announces Results of Phase 2/3 Trial of Advanced Phosphate Binder
Wed, 11/18/2009 - 3:32am
Genzyme Corporation today reported results of a phase 2/3 study of its advanced phosphate binder (APB). The trial met its primary endpoint, which was to show that the APB lowered phosphate levels effectively compared to placebo. However, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela® (sevelamer carbonate). Based on these results, the company is not planning to pursue further clinical development of the APB. Genzyme was seeking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela. In the study, Renvela and the APB both effectively lowered patients’ phosphorus levels. Most adverse events associated with both Renvela and the APB were mild in nature, and the most frequently reported events were gastrointestinal disorders. The trial was a randomized, double-blind, placebo-controlled study that enrolled 349 adult hemodialysis patients with hyperphosphatemia. It included seven arms: low, medium and high dose APB; low, medium and high dose Renvela, and placebo. It included a two-week screening period, a two-week washout period, and a three-week treatment period.