A Topical Non-steroidal Anti-inflammatory for Atopic Dermatitis

治疗特应性皮炎的外用非甾体抗炎药

基本信息

批准号：
8450681
负责人：
Braham Shroot
金额：
$ 99.9万
依托单位：
SIGNUM BIOSCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8450681
关键词：
2-cyclopentyl-5-(5-isoquinolylsulfonyl)-6-nitro-1H-benzo(D)imidazole Adolescent Adverse effects Affect Age Allergic Anti-Inflammatory Agents Anti-inflammatory Antihistamines Atopic Dermatitis Atrophic Award Calcineurin inhibitor Cardiotoxicity Cellular Infiltration Child Childhood Chronic Clinical Research Collaborations Cream Cysteine Data Delayed Hypersensitivity Dermal Development Disease Drug Compounding Drug Formulations Drug Kinetics Eczema Edema Endothelial Cells Erythema Etiology G Protein-Coupled Receptor Genes Gel Generations Grant Homeostasis IL8 gene In Vitro Infant Inflammation Inflammation Mediators Inflammatory Interleukin-17 Interleukin-4 Interleukin-6 Investigational Drugs Lead Manuscripts Methods Modeling Pathogenesis Pathology Peer Review Penetration Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Prevalence Process Receptor Signaling Research Safety Site Skin Steroids Symptoms TNF gene Testing Therapeutic Therapeutic Agents Time Topical application Toxicology Wound Healing age group analog analytical method base cytokine drug candidate drug metabolism improved in vivo novel novel therapeutics pre-clinical preclinical safety process optimization public health relevance scale up screening skin disorder skin irritation small molecule therapy development

项目摘要

DESCRIPTION (provided by applicant): Atopic dermatitis is a chronic dermatological condition afflicting mostly infants and young children. Current treatments are associated with a wide range of side effects therefore development of novel therapeutic agents that are efficacious and have an improved safety profile is needed. Although disease etiology has yet to be fully understood, skin inflammation is known to be critically involved in the disease pathology. Signum has identified novel potent topical anti-inflammatory agents called isoprenylcysteines (IPCs) with no detectable adverse affects. The proposed Phase II research plan will identify one lead compound and one backup for preclinical development and will establish the analytical methods, process development and formulation necessary to conduct IND-enabling studies (e.g. pharmacokinetic, toxicology and safety pharmacology determination). Together, the data generated from these studies will allow Signum to prepare and submit an IND for treatment of atopic dermatitis.

描述（由申请人提供）：特应性皮炎是一种慢性皮肤病，主要是婴儿和幼儿。当前的处理与广泛的副作用有关，因此需要有效的新型治疗剂的发展，并且需要改善安全性。尽管疾病的病因尚未完全了解，但已知皮肤炎症与疾病病理学有关。 Signum已确定了新型的有效局部抗炎药，称为异ony膜样机（IPC），没有可检测到的不良影响。拟议的II期研究计划将确定一种铅化合物和一种用于临床前开发的备份，并将建立进行辅助研究所必需的分析方法，过程开发和公式（例如，药代动力学，毒理学和安全药理学确定）。从这些研究中产生的数据一起将使Signum可以准备并提交IND以治疗特应性皮炎。