A Topical Non Steroidal Anti-inflammatory for Rosacea

治疗红斑痤疮的外用非类固醇抗炎药

基本信息

批准号：
8500104
负责人：
Edwardo Eddie Perez
金额：
$ 97.83万
依托单位：
SIGNUM BIOSCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-01 至 2015-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8500104
关键词：
American Anti-Inflammatory Agents Anti-inflammatory Award Cardiotoxicity Cavia Cells Chronic Clinical Clinical Research Clinical Trials Conduct Clinical Trials Cream Cysteine Cytochrome P450 Dermal Development Disease Drug Formulations Drug Kinetics Edema Ensure Erythema Etiology Event Face Flushing Glucocorticoids Goals Hepatic Homeostasis IL8 gene In Vitro Inflammation Inflammatory Interleukin-17 Interleukin-4 Interleukin-6 Investigational Drugs Lead Left Lesion Life Lotion Metronidazole Miniature Swine Modeling Neutrophil Infiltration Nodule Non-Rodent Model Oryctolagus cuniculus Pathology Patients Penetration Performance Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Phase III Clinical Trials Pregnancy Procedures Production Program Development Qualifying Rattus Redness Reproduction Risk Rosacea Safety Site Skin Small Business Innovation Research Grant TNF gene Telangiectasis Therapeutic Therapeutic Agents Time Topical application Toxic effect Toxicokinetics Toxicology Work analog analytical method azelaic acid clinical application cytokine drug candidate improved in vivo Model irritation manufacturing process method development mouse model novel patient population pre-clinical preclinical efficacy preclinical safety reproductive safety study skin disorder

项目摘要

DESCRIPTION (provided by applicant): Rosacea is a chronic dermatological condition characterized by flushing, erythema, papules, pustules, inflammatory nodules and telangiectasia. Although disease etiology remains unclear, skin inflammation has been identified as the main contributor to disease pathology. Isoprenylcysteine (IPC) analogs represent a novel class of topical anti-inflammatory compounds being developed as therapeutic agents for rosacea. As part of the Phase II SBIR project, Signum identified a lead investigational new drug (IND)-candidate, SIG990 which demonstrated strong efficacy in in vitro and in vivo models. Through pharmacokinetic and safety pharmacology studies, the preclinical safety profile for SIG990 was established. In the renewal application, we propose to continue SIG990's development path towards clinical application and FDA approval by conducting further safety assessment of drug product toxicity. Upon completion of the proposed aims, Signum will enter SIG990 into the Phase III clinical trials.

描述（由申请人提供）：酒渣鼻是一种慢性皮肤病学，其特征是潮红，红斑，丘疹，脓疱，炎症结节和telangiectia。尽管疾病的病因尚不清楚，但皮肤炎症已被确定为疾病病理学的主要因素。亚肾上腺素半胱氨酸（IPC）类似物代表了一种新型的局部抗炎化合物，作为酒渣鼻的治疗剂。作为II期SBIR项目的一部分，Signum确定了一种铅研究新药（IND） - 候选剂Sig990，该药物在体外和体内模型中表现出强大的功效。通过药代动力学和安全药理学研究，建立了SIG990的临床前安全性。在续签应用中，我们建议通过对药物毒性进行进一步的安全评估来继续Sig990的临床应用和FDA批准的发展路径。拟议的目标完成后，Signum将进入III期临床试验中的SIG990。