Amgen’s investigational AMG 416 succeeded in its final late-stage study for secondary hyperparathyroidism in patients with chronic kidney disease.
The company announced results from the head-to-head Phase III study comparing AMG 416 with its in-house rival Sensipar (cinacalcet) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CDK) receiving hemodialysis. According to the company, the study met its primary endpoint of non-inferiority, measured as the achievement of greater than 30 percent reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels during the Efficacy Assessment Phase (EAP), defined as the period between weeks 20 and 27.
Additionally, AMG 416 was statistically significantly superior to Sensipar in the secondary endpoints of the proportion of patients achieving greater than 50 percent and greater than 30 percent PTH reduction from baseline during EAP. The company said that there was no difference between the treatment arms in the mean number of days of vomiting or nausea per week in the first eight weeks, another secondary endpoint.
“These findings, combined with results from two positive placebo-controlled studies of more than 1,000 patients, add to the growing body of evidence that reinforce the promise of AMG 416 for hemodialysis patients with secondary hyperparathyroidism,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “The management of this disease in patients with chronic kidney disease is a complex process, and at Amgen, we are committed to building upon our leadership in nephrology to provide patients with an innovative therapy that can be administered intravenously along with hemodialysis.”
SHPT is often found in patients undergoing dialysis whose parathyroid glands kick into action as kidney function declines, generating dangerous hormone levels as the body attempts to maintain the proper level of calcium and phosphorus. Amgen acquired rights to AMG 416 through its $315 million acquisition of KAI in July 2012. Amgen already sells Sensipar, an oral drug indicated for SHPT; however the company believes there is a significant new market for an IV formulation that can be delivered during hemodialysis.
The investigational drug did come with side effects. Treatment-emergent events related to cardiac failure were reported in 3 percent of patients who received AMG 416 versus 0.6 percent in the Sensipar group. Additionally, fatal adverse events were reported in 2.7 percent for the AMG 416 group and 1.8 percent for the Sensipar group.