Accelerated Discovery and Development of New Pain Therapeutics

描述（由申请人提供）： 神经性疼痛是癌症、糖尿病、病毒感染和其他原因的常见并发症。尽管医生目前采用多种治疗来管理中度至重度神经性疼痛，包括非甾体抗炎药、阿片类药物、三环类抗抑郁药、抗癫痫药物、阿托宁-去甲肾上腺素再摄取抑制剂等，但许多患者仍未得到充分治疗。目前批准的药物的不良成功归因于疗效不足和剂量限制性毒性。这种未满足的临床需求已经产生了许多努力来鉴定用于治疗神经性疼痛的新型治疗剂，但这些努力中的大多数集中在鉴定先前已显示在该领域具有一定功效的药物类别的其他成员。毫不奇怪，许多这些代理人提供了什么是已经在使用的改进。通过我们的专有技术，Aestus Therapeutics已经确定了新的物质类别，这些物质可能通过新的机制有效治疗神经性疼痛。这种方法特别有希望针对高比例的患者谁是难治性既定疗法。虽然神经性疼痛有许多原因，但带状疱疹后神经痛（PHN）是研究新型镇痛剂的特别有用的模型。PHN通常被定义为带状疱疹皮疹消退后与带状疱疹相关的疼痛持续三个月以上。在美国，每年报告的带状疱疹新病例超过一百万例。与PHN相关的疼痛通常是中度严重的，并且对已建立的治疗反应不良。我们建议的重点是进行一项临床阶段2a的原则性研究，以确定其中一种已确定的产品在7天内给药时是否可能有效改善PHN疼痛。研究的积极结果将使我们能够通过与一家大型制药公司合作进行后期临床研究，向FDA提交新药申请，并将产品推向市场，造福患者和社会。 公共卫生相关性： 神经性疼痛患者往往成为全球残疾，是医疗资源的重度用户。目前的治疗方法疗效有限，并且存在副作用问题。通过我们的专有技术，已经确定了一类新的化合物，可以通过新的机制有效地治疗神经性疼痛。这种方法特别有希望针对高比例的患者谁是难治性既定疗法。本项目的重点是在临床上建立概念证明，重点是带状疱疹后神经痛患者。

DESCRIPTION (provided by applicant): Neuropathic pain is a common complication of cancer, diabetes mellitus, viral infections, and other causes. Although physicians currently employ a variety of treatments to manage moderate to severe neuropathic pain, including non-steroidal anti-inflammatory drugs, opioids, tricyclic antidepressants, anti- seizure medications, serotonin-norepinephrine reuptake inhibitors, and others, many patients are still inadequately treated. The poor success with the currently approved agents has been attributed to both inadequate efficacy and dose limiting toxicity. This unmet clinical need has generated numerous efforts to identify novel therapeutic agents for the treatment of neuropathic pain, but most of these efforts have focused on identifying additional members of drug classes that have previously shown to have some efficacy in this area. Not surprisingly, many of these agents offer little improvement over what is already in use. By means of our proprietary technology, Aestus Therapeutics has identified new classes of substances that may prove effective in treating neuropathic pain by means of novel mechanisms. This approach is particularly promising for targeting the high percentage of patients who are refractory to established therapies. While there are many causes of neuropathic pain, postherpetic neuralgia (PHN) is a particularly useful model for investigating novel analgesic agents. PHN is commonly defined as persistence of the pain associated with herpes zoster for more than three months after resolution of the herpes zoster rash. In the United States more than one million new cases of herpes zoster are reported each year. The pain associated with PHN is typically moderately severe and poorly responsive to established therapies. The focus of our proposal is to conduct a clinical phase 2a proof of principle study to determine whether one of the identified products is likely to be effective at improving PHN pain when administered over a seven day period. A positive outcome of the study will enable us to commercialize the product by partnering with a large pharmaceutical company for late stage clinical studies, filing New Drug Application at FDA and market the product to the benefit of patients and society. PUBLIC HEALTH RELEVANCE: Neuropathic pain patients tend to become globally disabled and are heavy users of healthcare resources. Current therapies have limited efficacy and issues with side effects. By means of our proprietary technology a new class of compounds has been identified that may prove effective in treating neuropathic pain by means of novel mechanisms. This approach is particularly promising for targeting the high percentage of patients who are refractory to established therapies. The focus of the present project is to establish proof of concept in the clinic, focusing on patients suffering postherpetic neuralgia.