NS-101(Neuracle Science)(NS-101(Neuracle Science)) - 在研适应症：神经性听力损失，神经系统变性病，肌萎缩侧索硬化_专利_临床

概要

基本信息

药物类型

抗体

别名

靶点-

作用机制-

治疗领域

神经系统疾病耳鼻咽喉疾病内分泌与代谢疾病+ [1]

在研适应症

神经性听力损失神经系统变性病肌萎缩侧索硬化

非在研适应症

阿尔茨海默症

原研机构

Neuracle Science Co., Ltd.初创企业

在研机构

Neuracle Science Co., Ltd.初创企业

非在研机构

REYON PHARMACEUTICAL Co., Ltd.

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 NS-101(Neuracle Science) 相关的临床试验

NCT06249919 / Recruiting临床1/2期

A Phase 1b/2a, Double-blinded, Placebo-controlled, Multiple Doses, 2 Step-up Study Evaluating the Safety, Tolerability, PK/PD and Efficacy of Systemic NS101 in Healthy Volunteers and SSNHL Patients

The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy.
The main questions it aims to answer are:
1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5
2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy.
Patients and heathly volunteers will be given NS101 15mg/kg or 30mg/kg systemically less than 3 months per protocol.
This is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.

开始日期2024-01-19

申办/合作机构

Neuracle Science Co., Ltd.初创企业

[+3]

NCT05143463 / Completed临床1期

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous NS101 Infusion in Healthy Volunteers

Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study.
The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis.

开始日期2021-11-04

申办/合作机构

Neuracle Science Co., Ltd.初创企业

100 项与 NS-101(Neuracle Science) 相关的临床结果

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100 项与 NS-101(Neuracle Science) 相关的转化医学

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100 项与 NS-101(Neuracle Science) 相关的专利（医药）

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4

项与 NS-101(Neuracle Science) 相关的文献（医药）

2021-12-01·Cancer Letters1区 · 医学

IDO1/TDO dual inhibitor RY103 targets Kyn-AhR pathway and exhibits preclinical efficacy on pancreatic cancer

1区 · 医学

Article

作者: Xing, Zikang ; Liu, Hongrui ; Li, Tianqi ; Guo, Leilei ; Yang, Qing ; Fang, Xin ; Zhang, Shengnan ; Shi, Lei ; Li, Weirui ; Liang, Heng ; Kuang, Chunxiang

Indoleamine 2,3-dioxygenase 1 (IDO1) catalyzing the conversion of tryptophan (Trp) to kynurenine (Kyn) in kynurenine pathway (KP) is involved in the immunosuppression in pancreatic cancer (PC), but the value of IDO1 as an independent prognostic marker for PC is uncertain. Moreover, the correlation between tryptophan 2,3-dioxygenase (TDO), an isozyme of IDO1, and PC is largely unknown. Using TCGA database, the correlation between IDO1 and/or TDO expression and PC patients' survival was analyzed. The expressions of IDO1 and TDO in PC cells and PC mice were examined. The effects of IDO1, TDO or dual inhibition on IDO1 and TDO effector pathway (Aryl hydrocarbon receptor, AhR) and on migration and invasion of PC cells were investigated. The block effect of IDO1/TDO dual inhibitor RY103 on KP was evaluated. The preclinical efficacy of RY103 and its immunomodulatory effect on KPIC orthotopic PC mice and Pan02 tumor-bearing mice were explored. Results showed that IDO1/TDO co-expression is an independent prognostic marker for PC. RY103 can significantly block KP and target Kyn-AhR pathway to blunt the migration and invasion of PC cells, exhibit preclinical efficacy and ameliorate IDO1/TDO-mediated immunosuppression in PC mice.

2012-06-01·Cancer Chemotherapy and Pharmacology4区 · 医学

RY10-4, a novel anti-tumor compound, exhibited its anti-angiogenesis activity by down-regulation of the HIF-1α and inhibition phosphorylation of AKT and mTOR

4区 · 医学

Article

作者: Pingping Xue ; Jinlan Ruan ; Chaomei Xiong ; Xuenong Zhang ; Qianying Yuan ; Ziwei Liu

PURPOSETo assess the anti-angiogenesis potential and mechanism of RY10-4, a derivative of protoapigenone, which was verified the broad-spectrum anti-tumor activities by previous study.METHODSRY10-4 and RY10-3 were synthesized according to the procedure described. Breast cancer cells MCF-7 and MDA-MB-231 that got the best performance in the previous anti-tumor activity screening were selected for further anti-cancer mechanism research. Firstly, cells proliferation assay of RY10-4 and RY10-3 was used to demonstrate the fact that the 4-hydroxy-2,5-cyclohexadien-1-one system would be the efficient pharmacophore of RY10-4. Then, a series of assays such as human umbilical vein endothelial cells (HUVECs) proliferation assay, HUVECs migration, tube network formation and morphological observations of zebrafish were applied to confirm its anti-angiogenesis activity. Upon RY10-4 treatment, the HIF-1α and VEGF were analyzed by western blot in normoxic and hypoxic conditions, meanwhile the PI3K-AKT-mTOR pathway-related protein such as AKT, p-AKT, mTOR and p-mTOR was also analyzed.RESULTSIn the MCF-7, MDA-MB-231 and HUVECs proliferation assay, RY10-4 that has 4-hydroxy-2,5-cyclohexadien-1-one system showed distinct advantage compared with RY10-3. Tests had verified the anti-angiogenesis capability of RY10-4. Down-regulation of the HIF-1α and inhibition phosphorylation levels of AKT and mTOR were found to be the pathway that RY10-4 exerts its functions on anti-angiogenesis.CONCLUSIONSThe structure of 4-hydroxy-2,5-cyclohexadien-1-one should be the effective pharmacophore of RY10-4. RY10-4 got fine performance in anti-tumor and anti-angiogenesis assay, and thus, the quinol compound will be the new hot-spot for further anti-tumor agency development.

Signal Transduction and Targeted Therapy

Both IDO1 and TDO contribute to the malignancy of gliomas via the Kyn–AhR–AQP4 signaling pathway

Article

作者: Tao, Bangbao ; Zheng, Yuanting ; Yang, Dan ; Du, Lisha ; Li, Tianqi ; Li, Weirui ; Yang, Qing ; Kuang, Chunxiang ; Xing, Zikang

AbstractIndoleamine 2,3-dioxygenase 1 (IDO1), indoleamine 2,3-dioxygenase 2 (IDO2), and tryptophan 2,3-dioxygenase (TDO) initiate the first step of the kynurenine pathway (KP), leading to the transformation of l-tryptophan (Trp) into l-kynurenine (Kyn) and other downstream metabolites. Kyn is known as an endogenous ligand of the aryl hydrocarbon receptor (AhR). Activation of AhR through TDO-derived Kyn is a novel mechanism to support tumor growth in gliomas. However, the role of IDO1 and IDO2 in this mechanism is still unknown. Herein, by using clinical samples, we found that the expression and activity of IDO1 and/or TDO (IDO1/TDO) rather than IDO2 were positively correlated with the pathologic grades of gliomas. The expression of IDO1/TDO rather than IDO2 was positively correlated with the Ki67 index and overall survival. The expression of IDO1/TDO was positively correlated with the expression of aquaporin 4 (AQP4), implying the potential involvement of IDO1/TDO in glioma cell motility. Mechanistically, we found that IDO1/TDO accounted for the release of Kyn, which activated AhR to promote cell motility via the Kyn–AhR–AQP4 signaling pathway in U87MG glioma cells. RY103, an IDO1/TDO dual inhibitor, could block the IDO1/TDO–Kyn–AhR–AQP4 signaling pathway and exert anti-glioma effects in GL261 orthotopic glioma mice. Together, our results showed that the IDO1/TDO–Kyn–AhR–AQP4 signaling pathway is a new mechanism underlying the malignancy of gliomas, and suggest that both IDO1 and TDO might be valuable therapeutic targets for gliomas.

100 项与 NS-101(Neuracle Science) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
神经性听力损失	临床2期	韩国	Neuracle Science Co., Ltd.初创企业	2024-01-19
神经系统变性病	临床1期	加拿大	Neuracle Science Co., Ltd.初创企业	2021-11-04
肌萎缩侧索硬化	临床1期	-	Neuracle Science Co., Ltd.初创企业	-
阿尔茨海默症	临床前	-	REYON PHARMACEUTICAL Co., Ltd.	2021-11-04