THOUSAND OAKS, Calif., July 17, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a Phase 3 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 > 30 percent reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. Amgen obtained AMG 416 as part of the acquisition of KAI Pharmaceuticals, Inc. in July 2012 and these are the first results to be reported from the Phase 3 program.
In the AMG 416 group, 75.3 percent of patients achieved a > 30 percent reduction from baseline in PTH compared with 9.6 percent 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 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.
"Secondary hyperparathyroidism can be a challenging disease to manage and control. There is an important role for an effective calcimimetic that can be administered intravenously with hemodialysis to help treat this disease," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are encouraged by the results of this study and look forward to sharing results from a second placebo-controlled study later this year, and a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
Treatment-emergent adverse events (TEAEs) were reported in 91.7 and 81.1 percent of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in > 10 percent of patients who received AMG 416 included (AMG 416 vs placebo, respectively): blood calcium decreased (66.7 and 12.0 percent), diarrhea (14.3 and 10.0 percent), and muscle spasms (11.1 and 6.2 percent). Serious adverse events (SAEs) were reported in 24.6 and 27.4 percent of patients who received AMG 416 and placebo, respectively. TEAEs of nausea were reported in 9.1 and 7.3 percent of patients who received AMG 416 and placebo, respectively. TEAEs of vomiting were reported in 7.5 and 3.1 percent of patients treated with AMG 416 and placebo, respectively. TEAEs of hypocalcemia (symptomatic) were reported in 6.7 percent of patients who received AMG 416 versus none in the placebo group.
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