July 17 An experimental drug to reduce excess
parathyroid hormone levels in patients with chronic kidney
disease succeeded in meeting the primary and secondary goals of
a Phase III study, Amgen Inc said on Thursday.
More than 75 percent of patients who received the drug, AMG
416, saw their parathyroid hormone levels drop by more than 30
percent, compared with 9.6 percent who experienced a similar
reduction among those who got a placebo.
The result of the 515-patient, 26-week study was deemed to
be statistically significant, Amgen, the world's largest
biotechnology company, said.
Amgen obtained AMG 416 through its acquisition of Kai
Pharmaceuticals in 2012.
Secondary hyperparathyroidism (SHPT) is a serious condition
that often progresses among patients with chronic kidney disease
who are receiving dialysis. It develops as a response to
declining kidney function when the parathyroid glands increase
the production of the hormone.
AMG 416, which is administered intravenously, works by
binding to and activating the calcium-sensing receptor on the
Secondary goals of the study included the percent change
from baseline in serum phosphorus concentration between weeks 20
and 27, and corrected calcium concentration. In both cases, AMG
416 achieved statistically significant improvements compared
with placebo, Amgen said.
The rate of side effects reported during treatment was high
for both groups, occurring in 91.7 percent of the AMG 416
patients and 81.1 percent among the placebo group. These
included blood calcium reductions, diarrhea and muscle spasms.
Adverse side effects deemed to be serious were reported in
24.6 percent and 27.4 percent of patients who received AMG 416
and placebo, respectively.
"We are encouraged by the results of this study and look
forward to sharing results from a second placebo-controlled
study later this year," Amgen research chief Sean Harper said in
(Reporting by Bill Berkrot; Editing by Tom Brown)