ONO-5163: Phase III data

The double-blind, double-dummy, international Phase III Study 20120360 in 638 CKD patients showed that thrice-weekly IV AMG 416 given at the end of each hemodialysis treatment for 26 weeks met the primary endpoint of non-inferiority to daily oral cinacalcet in the proportion of patients with a >30% reduction from baseline in mean serum PTH levels during weeks 20-27. AMG 416 also met the secondary endpoints of superiority to cinacalcet in the proportion of patients achieving a >30% (68.2% vs. 57.7%) and a >50% (52.4% vs. 40.2%) reduction from baseline in mean serum PTH levels during weeks 20-27.

There was no difference between the treatment arms on the secondary endpoint of the mean number of days of vomiting or nausea per week in the first 8 weeks. Treatment-emergent adverse events reported included reduced blood calcium, nausea, vomiting and diarrhea. In the AMG 416 arm, 2.7% of patients experienced a fatal adverse event compared to 1.8% in the cinacalcet arm. Patients also received standard of care, which could include calcium supplements, vitamin D sterols and phosphate binders. ...