Amgen's Hormone-Imbalance Drug AMG 416 Shows Positive Results in Phase 3 Study

February 26, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The world’s largest independent biotech, Amgen is enjoying a brief glow from shareholders Thursday after announcing a late-phase clinical trial of its experimental hormone drug AMG 416 showed more efficacy in patients with secondary hyperparathyroidism and chronic kidney disease.

The news was particularly striking because it showed AMG 416 to be more effective even when pitted head-to-head with competitor Sensipar.

Amgen released the details of the Phase III study, which followed 683 patients over 26 weeks who had taken AMG 416 and compared their results against Amgen’s cinacalcet, known under the brand name Sensipar, a calcium moderator.

“AMG 416 was statistically significantly superior to cinacalcet in the secondary endpoints of the proportion of patients achieving greater than 50 percent (52.4 percent versus 40.2 percent) and greater than 30 percent (68.2 percent versus 57.7 percent) PTH reduction from baseline during the EAP,” said Amgen in a statement. “There was no difference between the treatment arms in the mean number of days of vomiting or nausea per week in the first eight weeks, another secondary endpoint.”

Its findings are striking because it shows the AMG 416 might be especially effective for patients undergoing dialysis, which can often cause the hormonal imbalance associated with secondary hyperparathyroidism.

“These findings, combined with results from two positive placebo-controlled studies of more than 1,000 patients, add to the growing body of evidence that reinforce the promise of AMG 416 for hemodialysis patients with secondary hyperparathyroidism," said Sean E. Harper, executive vice president of Research and Development at Amgen.

"The management of this disease in patients with chronic kidney disease is a complex process, and at Amgen, we are committed to building upon our leadership in nephrology to provide patients with an innovative therapy that can be administered intravenously along with hemodialysis," he said.

Patients studied during the trial saw a 50 percent reduction from baseline in mean pre-dialysis serum intact PTH during the EAP, as well as a greater than 30 percent reduction from baseline in mean pre-dialysis serum intact PTH during the EAP. They also saw fewer days of nausea or vomiting per week in the first eight weeks, a common side effect of the condition and its usual treatment forms.

Secondary hyperparathyroidism develops when kidney function begins to decline. As a result, the four small parathyroid glands in the neck ratchet up production of PTH in an effort to maintain normal levels of calcium and phosphorus. But that extra PTH production can’t create adequate serum calcium and phosphorus levels and with the stress of dialysis, many patients then develop a hormonal imbalance.

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