A Topical Non Steroidal Anti-inflammatory for Rosacea

描述(申请人提供)：酒渣鼻是一种慢性皮肤病，以潮红、红斑、丘疹、脓疱疹、炎性结节和毛细血管扩张为特征。尽管疾病病因尚不清楚，但皮肤炎症已被确定为疾病病理的主要贡献者。异丙基半胱氨酸(IPC)类似物代表了一类新的局部抗炎化合物，正被开发用于酒渣鼻的治疗。作为第二阶段SBIR项目的一部分，Signum确定了一种领先的研究新药(IND)候选药物SIG990，该药物在体外和体内模型中显示出强大的疗效。通过药代动力学和安全性药理学研究，建立了SIG990的临床前安全性模型。在续签申请中，我们建议通过对药品毒性进行进一步的安全性评估，继续走SIG990‘S的开发道路，走向临床应用和FDA批准。在拟议的AIMS完成后，Signum将使SIG990进入第三阶段临床试验。

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.