Further positive Ph III results for Amgen’s AMG 416 in secondary hyperparathyroidism

USA-based Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, has released positive data from 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 hemodialysis, met its primary and all secondary endpoints.

The primary endpoint was the proportion of patients with > 30% 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, formerly known as velcalcetide, which was similar in design and size.

In the AMG 416 group, 74.0% of patients achieved a > 30% reduction from baseline in PTH compared with 8.3% 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% among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -7.29% and 1.18% among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.