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：
9344766
负责人：
Edwardo Eddie Perez
金额：
$ 105.02万
依托单位：
SIGNUM BIOSCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-02-14 至 2020-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9344766
关键词：
Acne Adolescent Adverse effects Affect Age Anti-Inflammatory Agents Anti-inflammatory Antihistamines Applications Grants Atopic Dermatitis Back Calcineurin inhibitor Cardiovascular system Child Childhood Chromosome abnormality Chronic Clinical Clinical Research Clinical Trials Cutaneous Cyclic GMP Delayed Hypersensitivity Dermal Dermatologic Dermatology Development Disease Drowsiness Drug Kinetics Drug Packaging Drug Stability Erythema Etiology Formulation Fostering Funding Future Grant Head Human In Vitro Incidence Infant Inflammation Inflammatory Interleukin-4 Investigational Drugs Investigational New Drug Application Lead Licensing Local Lymph Node Assay Malignant Neoplasms Mediator of activation protein Miniature Swine Oral Ovalbumin Oxazolone Pathogenesis Pathology Pediatrics Penetration Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Phase II Clinical Trials Prevalence Production Pruritus Rattus Reporting Research Safety Site Skin Small Business Innovation Research Grant Staphylococcus aureus Steroids TLR4 gene TSLP gene Testing Therapeutic Therapeutic Agents Thinness Time Topical application Toxic effect Toxicology Validation age group analog analytical method associated symptom drug candidate genotoxicity hypothalamic-pituitary-adrenal axis improved inhibitor/antagonist micronucleus mouse model novel novel therapeutics phase I trial preclinical development process optimization product development programs reduce symptoms research clinical testing respiratory screening skin disorder small molecule

项目摘要

SUMMARY 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 two novel potent topical anti-inflammatory agents (lead compound - SIG1451, backup compound – SIG1456) called isoprenylcysteines (IPCs) with no detectable adverse affects. The proposed Phase IIB research plan will enable the filing of an investigational new drug (IND) application for the first in human trials in AD. In addition this grant proposal will buttress Post-IND clinical efforts by completing additional juvenile safety and continue drug substance and drug product development for Phase II clinical trials.

概括特应性皮炎是一种慢性皮肤病，主要影响婴儿和幼儿。当前的治疗与广泛的副作用有关，因此开发了新型治疗剂这是有效的，需要提高安全性。尽管病因学尚未完全理解，已知皮肤炎症与疾病病理学非常重要。 Signum已确定两种新型潜在局部抗炎剂（铅化合物-SIG1451，备用化合物-SIG1456）没有可检测的不良影响，称为异on-囊样（IPC）。拟议的IIB阶段研究计划将启用对AD的人类试验中的第一个新药（IND）申请提交。此外该赠款提案将通过完成额外的少年安全并继续 II期临床试验的药物和药物产品开发。