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临床前,随机第一阶段和同情性使用评估REGN4461,一种用于治疗勒素缺乏症的勒素受体激素抗体

Judith Y Altarejos¹, Jeffrey Pangilinan¹, Simona Podgrabinska¹

¹Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.

Science translational medicine

|November 22, 2023

概括

一个新的抗体,REGN4461,激活了叶黄素受体信号,可能治疗肥胖和与低叶黄素水平相关的代谢疾病. 这种疗法在临床前模型和早期人体试验中对体重控制和肝脏健康显示出有前途.

科学领域:

代谢性疾病研究研究.
内分泌学在内分泌学.
药理学药理学是指药理学的学科.

背景情况:

莱普-莱普受体 (LEPR) 信号传递对于代谢调节至关重要.
瘦素或LEPR信号的缺陷会导致严重的肥胖和代谢障碍,包括肝病.
恢复勒-LEPR信号传输是这些疾病的治疗目标.

研究的目的:

开发和评估一种新型单克隆抗体 (mAb),可以激活人类LEPR.
在临床前模型和人体研究中评估 REGN4461 (米巴瓦迪马布) 的疗效和安全性.

主要方法:

开发一种完全人类单克隆抗体 (REGN4461),向人类瘦素受体.
在瘦素淘汰赛小鼠的临床前测试和一般化脂质营养不良的小鼠模型.
第1期随机,双盲,安慰剂对照研究,对超重或肥胖的个体进行,包括在非典型的局部脂质变症患者中同情使用.

主要成果:

REGN4461 在肥胖小鼠中使体重,食物摄入量,葡萄糖和胰岛素敏感性正常化.
它减轻了脂肪衰竭小鼠模型中的过,高血糖症,胰岛素耐药性,失脂症和肝胆固醇症.
在人类中,REGN4461降低了瘦素水平低 (<8 ng/ml) 的个体的体重,并在患有脂质营养不良的患者中改善了甘油三和肝脂肪.

结论:

REGN4461是一种有前途的LEPR mAb激动剂,具有潜在的临床益处.
该疗法可能有效治疗与低平素度相关的代谢和肝脏疾病.
REGN4461在早期人类试验中显示出可接受的安全性.

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