Second Phase 3 Registrational Study Meets Primary and All Secondary Endpoints
THOUSAND OAKS, Calif., Aug. 18, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a second placebo-controlled Phase 3 study evaluating AMG 416 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. These results follow the recent announcement of positive data from a prior placebo-controlled Phase 3 study of AMG 416 which was similar in design and size.
In the AMG 416 group, 74.0 percent of patients achieved a > 30 percent reduction from baseline in PTH compared with 8.3 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 -7.71 and -1.31 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -7.29 and 1.18 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant.
"The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
Treatment-emergent adverse events (TEAEs) were reported in 91.6 and 78.7 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 (61.0 and 8.3 percent), nausea (12.4 and 5.1 percent), muscle spasms (12.0 and 7.1 percent) and vomiting (10.4 and 7.1 percent). TEAEs of hypocalcemia (symptomatic) were reported in 7.2 percent of patients who received AMG 416 versus 0.4 percent in the placebo group. Serious adverse events (SAEs) were reported in 27.1 and 30.7 percent of patients who received AMG 416 and placebo, respectively.
This was a 26-week, randomized, double-blind, placebo-controlled study (study number 20120229) that evaluated the efficacy and safety of AMG 416 for the treatment of SHPT in 508 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by intravenous injection with each hemodialysis treatment. Doses ranged from a minimum of 2.5 mg to a maximum of 15 mg. Patients also received standard of care which could include calcium supplements, vitamin D sterols and phosphate binders, if prescribed by the individual physician.
Secondary endpoints included the proportion of patients with PTH ≤ 300 pg/mL during the EAP and the percent change from baseline during the EAP in values for PTH, serum cCa, corrected calcium-phosphorus product (cCa x P) and P.
About Secondary Hyperparathyroidism
Secondary HPT is a common and serious condition that is often progressive among patients with CKD and it affects many of the approximately two million people throughout the world who are receiving dialysis. The disorder develops early as an adaptive response to declining kidney function when the parathyroid glands (four small glands in the neck) increase the production of PTH in an effort to maintain normal levels of calcium and phosphorus. Ultimately, excess PTH production proves inadequate for maintaining normal serum calcium and phosphorus levels. When kidney disease progresses to the point where dialysis is needed to sustain life, SHPT manifests as abnormal PTH, calcium and phosphorus levels that, in turn, can lead to significant clinical consequences.
About AMG 416
AMG 416 is a novel calcimimetic agent in Phase 3 clinical development for the treatment of SHPT that is administed intravenously in patients with CKD who are receiving hemodialysis. AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.
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