AMG 416是一种实验性受体刺激剂，通过静脉注射作用于甲状旁腺上的钙离子敏感受体，起到降低甲状旁腺素的作用。
此次26周随机、双盲、安慰剂对照试验共有508位患者参与。用药20-27周后，74%使用AMG 416患者体内的甲状旁腺素下降幅度超过30%，远超过安慰剂组的8.3%。在血清磷(P)浓度浓度方面，AMG416下降浓度为7.71%，安慰剂为1.31%。
继发性甲状旁腺机能亢进属于慢性肾疾病的并发症。在全球范围内大约有200万名患者。
Amgen Inc.’s (AMGN - Analyst Report) shares were up 2.5% following the company’s announcement that AMG 416 (formerly known as velcalcetide) has met the primary as well as secondary endpoints in a randomized, double-blind, placebo-controlled 26-week long phase III study.
The study evaluated the efficacy and safety of AMG 416 in 515 chronic kidney disease (CKD) patients receiving hemodialysis and suffering from secondary hyperparathyroidism. Results showed that patients on AMG 416 achieved a statistically significant reduction in parathyroid hormone levels compared to patients on placebo (75.3% versus 9.3%).
Secondary hyperparathyroidism is a serious condition that occurs frequently and often advances in patients suffering from CKD. According to the press release issued by Amgen, secondary hyperparathyroidism affects a considerable number of patients out of almost two million dialysis-dependent patients across the world.
We remind investors that AMG 416 became a part of Amgen’s portfolio following its Jul 2012 acquisition of KAI Pharmaceuticals, Inc. These are the first phase III data reported on AMG 416.
Amgen intends to announce results from another placebo-controlled study later this year. Amgen is also conducting a head-to-head study evaluating AMG 416 in comparison with Sensipar. Results should be out in 2015.
Meanwhile, Amgen is working toward strengthening its pipeline. We expect 2014 to be a catalyst rich year for Amgen as it gears up to present data on several late stage candidates.
Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Actelion Ltd. (ALIOF), The Medicines Co. (MDCO - Analyst Report) andBiogen Idec Inc. (BIIB - Analyst Report). All these stocks carry a Zacks Rank #1 (Strong Buy).
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