Department of Clinical Chemistry and Informatics, Graduate School of Pharmaceutical Sciences, Kumamoto University, 5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan; Department of Pharmacy, University of Miyazaki Hospital, 5200 Kihara, Kiyotake-cho, Miyazaki 889-1692, Japan.
Department of Clinical Chemistry and Informatics, Graduate School of Pharmaceutical Sciences, Kumamoto University, 5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan.
Life Sci. 2024 Aug 1;350:122776. doi: 10.1016/j.lfs.2024.122776. Epub 2024 Jun 7.
Niemann-Pick disease type C (NPC) is a lysosomal lipid storage disorder characterized by progressive neurodegeneration and hepatic dysfunction. A cyclic heptasaccharide, 2-hydroxypropyl-β-cyclodextrin (HP-β-CD), is currently under clinical investigation for NPC, but its adverse events remain problematic. We previously identified that a cyclic octasaccharide, 2-hydroxypropyl-γ-cyclodextrin (HP-γ-CD), also ameliorated NPC manifestations with higher biocompatibility than HP-β-CD. However, preclinical studies describing the associations between the biodistribution and pharmacodynamics of these compounds, which are essential for clinical application, are still lacking. Here, we investigated these properties of HP-γ-CD by measuring its organ biodistribution and therapeutic effect after systemic and central administration. The effect of HP-γ-CD on disturbed cholesterol homeostasis appeared within several hours after exposure and persisted for several days in NPC model cells and mice. Tissue distribution indicated that only a small fraction of subcutaneously administered HP-γ-CD rapidly distributed to peripheral organs and contributed to disease amelioration. We found that a subcutaneous dose of HP-γ-CD negligibly ameliorated neurological characteristics because it has limited penetration of the blood-brain barrier; however, an intracerebroventricular microdose unexpectedly attenuated hepatic dysfunction without the detection of HP-γ-CD in the liver. These results demonstrate that central administration of HP-γ-CD can indirectly attenuate peripheral manifestations of NPC.
尼曼-匹克病 C 型(NPC)是一种溶酶体脂质贮积病,其特征是进行性神经退行性变和肝功能障碍。一种环状七聚糖,2-羟丙基-β-环糊精(HP-β-CD),目前正在 NPC 的临床研究中,但它的不良反应仍然是个问题。我们之前发现一种环状八聚糖,2-羟丙基-γ-环糊精(HP-γ-CD),也改善了 NPC 的表现,其生物相容性比 HP-β-CD 更高。然而,对于这些化合物的生物分布和药效之间的关联的临床前研究,这些关联对于临床应用至关重要,仍然缺乏。在这里,我们通过测量其在系统和中枢给药后的器官生物分布和治疗效果来研究 HP-γ-CD 的这些特性。暴露后数小时内,HP-γ-CD 对胆固醇稳态紊乱的影响就显现出来,并且在 NPC 模型细胞和小鼠中持续数天。组织分布表明,只有一小部分皮下给予的 HP-γ-CD 迅速分布到外周器官,并有助于疾病的改善。我们发现,皮下给予 HP-γ-CD 几乎不能改善神经特征,因为它对血脑屏障的穿透有限;然而,出乎意料的是,脑室内微剂量给药可以减轻肝功能障碍,而在肝脏中未检测到 HP-γ-CD。这些结果表明,HP-γ-CD 的中枢给药可以间接减轻 NPC 的外周表现。