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|Amgen Presents Pooled Phase 3 AMG 416 Data For The Treatment Of Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease|
"Secondary hyperparathyroidism is a complex and challenging condition that can be difficult to manage, as it may require patients to take demanding drug regimens multiple times a day," said
AMG 416 is a novel calcimimetic agent in clinical development for the treatment of SHPT in patients with CKD who are receiving hemodialysis. In the registrational programs, AMG 416 is administered intravenously at the end of dialysis. AMG 416 acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH. Sustained elevations in PTH are known to lead to significant clinical consequences for patients with CKD.
In the two Phase 3 placebo-controlled studies, an aggregate of 1,023 patients with moderate-to-severe SHPT (PTH greater than 400 pg/mL) on hemodialysis were randomized to receive intravenous AMG 416 or placebo three times a week. The primary endpoint of both studies was the proportion of patients achieving greater than 30 percent reduction in PTH during the Efficacy Assessment Phase, defined as weeks 20 through 27. Secondary endpoints included the proportion of patients with PTH less than or equal to 300 pg/mL, and percent reductions in PTH, albumin adjusted calcium (cCa), phosphate (P) and cCa x P. In the AMG 416 group, 74.7 percent of patients achieved a greater than 30 percent reduction from baseline in PTH compared with 8.9 percent in the placebo arm.
Furthermore, a statistically significant proportion of patients (51.5 percent) randomized to receive AMG 416 achieved PTH less than or equal to 300 pg/mL, compared with 5.9 percent in the placebo-controlled group, despite similar baseline mean PTH values of 724 pg/mL and 716 pg/mL, respectively. Significant reductions in phosphate as well as fibroblast growth factor 23 (FGF23) were also observed, with two-thirds of AMG 416-treated patients experiencing a greater than 30 percent reduction in FGF23 concentrations compared with 30 percent of placebo-treated patients.
Reductions in serum calcium were observed and symptomatic hypocalcemia occurred more frequently in patients treated with AMG 416 compared to placebo (7.0 percent versus 0.2 percent, respectively). Additional adverse events included muscle spasms and gastrointestinal symptoms (e.g. nausea and vomiting), and they were reported more frequently with AMG 416 compared with placebo. Rates of death, adjudicated major non-fatal cardiovascular events and seizures were similar in both groups.
"These positive pivotal data further underscore the potential of AMG 416 in reducing parathyroid hormone concentrations, and ultimately, in helping treat patients impacted by this challenging disease," said
About Secondary Hyperparathyroidism
About AMG 416
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amgen-presents-pooled-phase-3-amg-416-data-for-the-treatment-of-secondary-hyperparathyroidism-in-patients-with-chronic-kidney-disease-300090474.html