Amgen announced that more than 75% of hemodialysis patients who received the experimental drug AMG 416 (formerly known as velcalcetide) as part of a phase 3 study experienced a drop in their parathyroid hormone levels of more than 30%, compared with 9.6% for patients who received a placebo. The drug is being tested to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease, receiving hemodialysis.
The study also met its secondary endpoint, which included corrected calcium concentration and the percent change from baseline in serum phosphorus concentration observed between weeks 20 and 27. Both of these secondary endpoint results were statistically significant, the company reported.
"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, MD, 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."
AMG 416 is administered intravenously and binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.
About the study
This was a 26-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of AMG 416 for the treatment of SHPT in 515 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 that could include calcium supplements, vitamin D sterols and phosphate binders, if prescribed by the individual physician.