Second Phase III trial of AMG 416 success for Sec. Hyperparathyroidism - Amgen

Amgen announced that a second placebo-controlled Phase III study evaluating AMG 416 for the treatment of secondary Hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving haemodialysis, met its primary and all secondary endpoints.

The primary endpoint was the proportion of patients with more than 30 percent reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. These results follow the recent announcement of positive data from a prior placebo-controlled Phase III study of AMG 416 which was similar in design and size.In the AMG 416 group, 74.0 percent of patients achieved a more than 30 percent reduction from baseline in PTH compared with 8.3 percent in the placebo arm, a statistically significant result. Secondary endpoints included the percent change from baseline during the EAP in serum phosphorus (P) concentration (mean changes of -7.71 and -1.31 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -7.29 and 1.18 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.