A Topical Non Steroidal Anti-inflammatory for Rosacea

描述（由申请方提供）：酒渣鼻是一种慢性皮肤病，特征为潮红、红斑、丘疹、脓疱、炎性结节和毛细血管扩张。虽然疾病病因尚不清楚，但皮肤炎症已被确定为疾病病理学的主要贡献者。异戊二烯半胱氨酸（IPC）类似物代表了一类新型的局部抗炎化合物正在开发的治疗剂酒渣鼻。作为II期SBIR项目的一部分，Signum确定了一种主要的研究性新药（IND）候选药物SIG990，该药物在体外和体内模型中表现出强大的疗效。通过药代动力学和安全药理学研究，确立了SIG 990的临床前安全性特征。在更新申请中，我们建议通过对药品毒性进行进一步的安全性评估，继续SIG 990的临床应用和FDA批准的发展道路。在完成拟议目标后，Signum将把SIG990投入III期临床试验。

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.