Phase III trial of AMG 416 meets endpoints in Sec. Hyperparathyroidism-Amgen

Amgen has announced that a Phase III study evaluating AMG 416 (formerly known as velcalcetide) 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 more than 30% reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. In the AMG 416 group, 75.3% of patients achieved a more than 30% reduction from baseline in PTH compared with 9.6% 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 -9.63 and -1.60 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -6.69 and 0.58% among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.

Treatment-emergent adverse events (TEAEs) were reported in 91.7 and 81.1% of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in more than 10% of patients who received AMG 416 included (AMG 416 vs placebo, respectively): blood calcium decreased (66.7 and 12.0%), diarrhea (14.3 and 10.0%), and muscle spasms (11.1 and 6.2%). Serious adverse events (SAEs) were reported in 24.6 and 27.4% of patients who received AMG 416 and placebo, respectively.