CAMBRIDGE, Mass.—Genzyme Corp. said Nov. 18 that it has ended the development of a new phosphate binder for dialysis patients because the new drug did not work much better than its existing drug Renvela.
According to results from a phase 2/3 study, Genzyme’s advanced phosphate binder (APB) 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), according to the company.
“Based on these results, the company is not planning to pursue further clinical development of the APB,” Genzyme said in a news release.
Genzyme said it was trying 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, according to Genzyme.
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.
