(Adds future trial data detail)
July 17 An experimental drug proved effective in
a late-stage study in reducing excess levels of a hormone
associated with a serious condition often seen in patients with
chronic kidney disease requiring dialysis, Amgen Inc
said on Thursday.
More than 75 percent of patients who received the drug, AMG
416, had a drop in their parathyroid hormone levels of more than
30 percent, compared with 9.6 percent who experienced a similar
reduction among those who got a placebo.
Patients with chronic kidney disease who are receiving
dialysis often suffer from a progression of secondary
hyperparathyroidism (SHPT), a serious condition that develops in
response to declining kidney function when the parathyroid
glands increase production of the hormone.
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.
The drug, which is administered intravenously, works by
binding to and activating the calcium-sensing receptor on the
The study also met its secondary goals, which included the
percent change from baseline in serum phosphorus concentration
observed 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. The side
effects included blood calcium reductions, diarrhea and muscle
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
Amgen also said it expects data from a head-to-head trial
testing AMG 416 against its own Sensipar in 2015. Sensipar had
global sales of $270 million in the first quarter.
(Reporting by Bill Berkrot; Editing by Tom Brown and Leslie