Amgen announces positive Phase III results for AMG 416 in kidney disease

USA-based Amgen (Nasdaq: AMGN), the world's leading independent biotech firm, has said its Phase III study evaluating AMG 416 (formerly known as velcalcetide) in the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease, receiving hemodialysis, met its primary and all secondary endpoints.

It obtained AMG 416 in the  acquisition of KAI Pharmaceuticals in July 2012, with these being the first results to be reported from the Phase III program. The primary endpoint was the proportion of patients with a greater than 30% reduction from baseline in parathyroid hormone levels during an efficacy assessment phase defined as the period between weeks 20 and 27. In the group given AMG 416, 75.3% of patients achieved more than 30% reduction from baseline in parathyroid hormone compared with 9.6% in the placebo arm.

Secondary endpoints included the percent change from baseline during the efficacy assessment phase in serum phosphorus concentration, and corrected calcium concentration, which Amgen found to be statistically significant.