AMG 416 meets in second secondary hyperparathyroidism trial

Amgen Inc. (NASDAQ:AMGN) said IV AMG 416 met the primary endpoint vs. placebo in the 508-patient Phase III 20120229 trial to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. AMG 416 given thrice weekly for 26 weeks led to a greater proportion of patients with a greater than 30% reduction from baseline in parathyroid hormone (PTH) levels during weeks 20-27 (74% for AMG 416 vs. 8.3% for placebo, p-value not disclosed). All patients also received standard of care.

Last month, Amgen said AMG 416 -- a peptide calcimimetic that acts on the parathyroid gland to reduce production of PTH -- met the same primary endpoint in the nearly identical Phase III 20120230 trial. Data from a Phase III trial comparing AMG 416 to the company's cinacalcet are expected next year. Amgen markets cinacalcet, a second-generation calcimimetic, as Mimpara in the EU and as Sensipar in the U.S. (see BioCentury Extra, July 17). ...