Pharmaceutical Candidate Optimization (S.C., S.S.L.V.J., T.N., S.S.G., B.V.M.) and Discovery and Translational Medicine (S.M., A.A.H., G.R.G., V.K., A.D., S.B.), Biocon Bristol-Myers Squibb R&D Center (BBRC), Syngene International Ltd., Bangalore, India; Pharmaceutical Candidate Optimization (T.T.M.) and Discovery and Translational Medicine, Bristol-Myers Squibb India Pvt. Ltd. (M.R.), Biocon Bristol-Myers Squibb R&D Center (BBRC), Bangalore, India; BMS Fibrosis Drug Discovery, Research and Early Development, Princeton, New Jersey (B.A.Z.); and Pharmaceutical Candidate Optimization, Bristol-Myers Squibb Co., Princeton, New Jersey (Y.Z., M.S., H.S.)
Pharmaceutical Candidate Optimization (S.C., S.S.L.V.J., T.N., S.S.G., B.V.M.) and Discovery and Translational Medicine (S.M., A.A.H., G.R.G., V.K., A.D., S.B.), Biocon Bristol-Myers Squibb R&D Center (BBRC), Syngene International Ltd., Bangalore, India; Pharmaceutical Candidate Optimization (T.T.M.) and Discovery and Translational Medicine, Bristol-Myers Squibb India Pvt. Ltd. (M.R.), Biocon Bristol-Myers Squibb R&D Center (BBRC), Bangalore, India; BMS Fibrosis Drug Discovery, Research and Early Development, Princeton, New Jersey (B.A.Z.); and Pharmaceutical Candidate Optimization, Bristol-Myers Squibb Co., Princeton, New Jersey (Y.Z., M.S., H.S.).
J Pharmacol Exp Ther. 2021 Jan;376(1):29-39. doi: 10.1124/jpet.120.000291. Epub 2020 Oct 30.
Expression and functional changes in the organic anion transporting polypeptide (OATP)-multidrug resistance-associated protein (MRP) axis of transporters are well reported in patients with nonalcoholic steatohepatitis (NASH). These changes can impact plasma and tissue disposition of endo- and exogenous compounds. The transporter alterations are often assessed by administration of a xenobiotic or by transporter proteomic analysis from liver biopsies. Using gene expression, proteomics, and endogenous biomarkers, we show that the gene expression and activity of OATP and MRP transporters are associated with disease progression and recovery in humans and in preclinical animal models of NASH. Decreased OATP and increased MRP3/4 gene expression in two cohorts of patients with steatosis and NASH, as well as gene and protein expression in multiple NASH rodent models, have been established. Coproporphyrin I and III (CP I and III) were established as substrates of MRP4. CP I plasma concentration increased significantly in four animal models of NASH, indicating the transporter changes. Up to a 60-fold increase in CP I plasma concentration was observed in the mouse bile duct-ligated model compared with sham controls. In the choline-deficient amino acid-defined high-fat diet (CDAHFD) model, CP I plasma concentrations increased by >3-fold compared with chow diet-fed mice. In contrast, CP III plasma concentrations remain unaltered in the CDAHFD model, although they increased in the other three NASH models. These results suggest that tracking CP I plasma concentrations can provide transporter modulation information at a functional level in NASH animal models and in patients. SIGNIFICANCE STATEMENT: Our analysis demonstrates that multidrug resistance-associated protein 4 (MRP4) transporter gene expression tracks with nonalcoholic steatohepatitis (NASH) progression and intervention in patients. Additionally, we show that coproporphyrin I and III (CP I and III) are substrates of MRP4. CP I plasma and liver concentrations increase in different diet- and surgery-induced rodent NASH models, likely explained by both gene- and protein-level changes in transporters. CP I and III are therefore potential plasma-based biomarkers that can track NASH progression in preclinical models and in humans.
有机阴离子转运多肽(OATP)-多药耐药相关蛋白(MRP)转运体轴在非酒精性脂肪性肝炎(NASH)患者中的表达和功能变化已有报道。这些变化会影响内源性和外源性化合物的血浆和组织分布。这些转运体的改变通常通过给予外源性化合物或通过肝活检的转运体蛋白质组学分析来评估。本研究使用基因表达、蛋白质组学和内源性生物标志物,证明 OATP 和 MRP 转运体的基因表达和活性与人类和 NASH 的临床前动物模型中的疾病进展和恢复有关。在两个脂肪变性和 NASH 患者队列中,以及在多个 NASH 啮齿动物模型中,均发现 OATP 表达降低和 MRP3/4 基因表达增加。已经确定原卟啉 I 和 III(CP I 和 III)是 MRP4 的底物。在四个 NASH 动物模型中,CP I 血浆浓度显著增加,表明转运体发生了变化。与假手术对照相比,在胆管结扎的小鼠模型中,CP I 血浆浓度增加了高达 60 倍。与给予标准饮食的小鼠相比,在胆碱缺乏氨基酸定义的高脂肪饮食(CDAHFD)模型中,CP I 血浆浓度增加了 3 倍以上。相比之下,CP III 血浆浓度在 CDAHFD 模型中没有改变,尽管在其他三个 NASH 模型中增加了。这些结果表明,在 NASH 动物模型和患者中,跟踪 CP I 血浆浓度可以提供转运体在功能水平上的调制信息。意义陈述:我们的分析表明,多药耐药相关蛋白 4(MRP4)转运体基因表达与非酒精性脂肪性肝炎(NASH)的进展和患者的干预相关。此外,我们还表明,原卟啉 I 和 III(CP I 和 III)是 MRP4 的底物。CP I 和 III 血浆和肝脏浓度在不同的饮食和手术诱导的 NASH 啮齿动物模型中增加,这可能是由于转运体的基因和蛋白水平的变化。因此,CP I 和 III 是潜在的基于血浆的生物标志物,可以在临床前模型和人类中跟踪 NASH 的进展。