A Topical Non-steroidal Anti-inflammatory for Atopic Dermatitis

摘要 特应性皮炎是一种慢性皮肤病，主要困扰婴儿和幼儿。当前 治疗与广泛的副作用有关，因此开发新的治疗药物 需要有效的和有改进的安全状况的产品。虽然疾病病因学尚未完全 据了解，皮肤炎症被认为与疾病的病理密切相关。Signum已经确认 两种新型高效局部抗炎药(先导化合物-SIG1451，备份化合物-SIG1456) 称为异丙基半胱氨酸(IPC)，没有可检测到的不良反应。拟议的第二阶段B研究计划将 允许在AD的人体试验中首次提交研究用新药(IND)申请。此外 这项拨款提案将通过完成额外的青少年安全性来支持IND后临床工作，并继续 第二阶段临床试验的药物物质和药物产品开发。

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.