Amgen's kidney dialysis drug clears its first Phase III hurdle

Amgen R&D chief Sean Harper

Amgen's ($AMGN) in-development treatment for patients on kidney dialysis met its primary and secondary goals in a late-stage trial, step one in the drug's three-part Phase III program.

Dubbed AMG 416, the treatment is designed to relieve symptoms of secondary hyperparathyroidism (SHPT), a disorder that afflicts patients with chronic kidney disease receiving hemodialyis. SHPT arises when the body attempts to adapt to declining kidney function by increasing production of parathyroid hormone to maintain healthy levels of calcium and phosphorus. Once dialysis kicks in, that excess parathyroid hormone becomes clinically dangerous, and AMG 416 is designed to intervene by interacting with the parathyroid gland.

In its first Phase III study, the drug did just that. AMG 416 met its primary endpoint of reducing baseline parathyroid hormone levels by more than 30%, with 75.3% of patients in the treatment arm crossing that threshold compared to 9.6% on placebo. The intravenous therapy also came through on secondary endpoints of change from baseline in concentration of serum phosphorus concentration and corrected calcium, Amgen said.

Now the company is waiting on results from a second placebo-controlled study, due later this year, and a trial comparing AMG 416 to its own Sensipar (cinacalcet), which will report out in 2015, R&D chief Sean Harper said in a statement.

"Secondary hyperparathyroidism can be a challenging disease to manage and control," Harper said. "There is an important role for an effective calcimimetic that can be administered intravenously with hemodialysis to help treat this disease."

The trial enrolled 515 dialysis patients, administering AMG 416 or placebo three times per week alongside standard of care. The most common adverse events were decreases in blood calcium, diarrhea and muscle spasms.

Amgen picked up AMG 416 in its $315 million deal for KAI Pharmaceuticals back in 2012.

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