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ARTICLE | Clinical News

AMG 416 meets in secondary hyperparathyroidism trial

July 18, 2014 12:23 AM UTC

Amgen Inc. (NASDAQ:AMGN) said IV AMG 416 met the primary endpoint vs. placebo in the 515-patient Phase III 20120230 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 vs. placebo (75.3% vs. 9.6%, p-value not disclosed).

Amgen said AMG 416 also met all secondary endpoints in the trial, including significantly reducing mean serum phosphorous concentration and mean corrected calcium concentration from baseline at weeks 20-27 vs. placebo. Patients also received standard of care, which could include calcium supplements, vitamin D sterols and phosphate binders. AMG 416 is a peptide calcimimetic that acts on the parathyroid gland to reduce production of PTH. ...