Merck & Co., Inc., 213 East Grand Avenue, South San Francisco, CA, 94080, United States.
AK Biotechnologies, LLC 3812 Verdure Lane, Zionsville, IN, 46077, United States.
Mol Metab. 2021 Apr;46:101152. doi: 10.1016/j.molmet.2020.101152. Epub 2020 Dec 29.
FGF19 and FGF21 have shown therapeutic promise since their discovery, attested by the fact there are at least 5 assets that activate the FGFR/KLB pathway and one FGF19 analog in clinical development.
We performed a detailed analyses of published preclinical and clinical data to offer insights into the mechanism of action, as well as PK/PD and efficacy data of the clinical assets.
Scouring the literature, we offer mechanistic insights from preclinical data using rodents and non-human primates and pharmacodynamic data from clinical studies.
The basic and applied science around endocrine FGFs has evolved exponentially over the years with FGF19 and FGF21 analogs are now entering Phase 3 clinical research.
自发现以来，FGF19 和 FGF21 显示出了治疗潜力，至少有 5 种激活 FGFR/KLB 途径的资产和 1 种 FGF19 类似物正在临床开发中，这证明了这一点。
我们对已发表的临床前和临床数据进行了详细分析，以深入了解这些资产的作用机制、PK/PD 和疗效数据。
通过对文献的仔细研究，我们提供了来自啮齿动物和非人类灵长类动物的临床前数据的机制见解，以及来自临床研究的药效学数据。
内分泌 FGF 多年来的基础和应用科学发展迅速，FGF19 和 FGF21 类似物现在已经进入 3 期临床研究。
