In a second Phase 3 study, Amgen’s investigational treatment for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are receiving hemodialysis achieved its primary and secondary endpoints, the drug manufacturer announced on August 18, 2014.
According to Amgen, AMG 416 is a calcimimetic agent that is administered intravenously to treat SHPT in CKD patients who are receiving hemodialysis. AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland, which, in turn, decreases the production of parathyroid hormone (PTH).
The efficacy and safety of the drug was evaluated in a 26-week, placebo-controlled study that enrolled 508 CKD patients receiving hemodialysis. The participants were randomized to receive AMG 416 in doses that ranged from 2.5 to 15 mg or placebo 3 times per week by intravenous injection with each hemodialysis treatment.
During the trial’s Efficacy Assessment Phase, defined as the period between weeks 20 and 27, nearly three-quarters of patients taking AMG 416 achieved more than a 30% reduction in PTH levels from baseline, compared to 8.3% of the placebo arm—a statistically significant difference.
"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,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a press release
. “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.”
Dr. Harper said Amgen expects to release the results of a head-to-head study comparing AMG 416 to cinacalcet (Sensipar), another calcimimetic agent, next year.
In the present study, treatment-emergent adverse events were reported in 91.6% of patients who received AMG 416 and 78.7% of those who received placebo. Nausea, vomiting, and muscle spasms were among the issues reported following the initiation of the treatment.