A New Topical Antiandrogen Benefits Acne Treatment

一种新的外用抗雄激素有益于痤疮治疗

• 批准号: 7155625
• 负责人: CHARLES C-Y SHIH
• 金额: $ 44.6万
• 依托单位: ANDROSCIENCE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-19 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7155625
• 关键词: androgen receptor; androgens; clinical trials; human; toxicology

DESCRIPTION (provided by applicant): Acne is the second most expensive skin disease, resulting in $2.23 billion in medical spending annually. Although the overall health is not impaired, acne can produce cutaneous and emotional scars that last a lifetime. It is not surprising that there is high willingness to pay for acne treatment, and the market is expected to grow to $12 billion. Currently, available medicines are mainly used to treat symptoms and are associated with severe drawbacks, such as skin irritation, requiring long-term treatment, teratogenesis, and acquisition of antibiotic resistance. Androgens, which act through androgen receptor to express their biological response, play an important role in the development of acne, i.e., the cause of disease. In theory, use of an androgen receptor inhibitor should induce symptom relief for all types of acne and more importantly, intervenes in the progression from comedones to the more severe, scar-causing inflammatory lesions. Currently, there is no topical androgen receptor inhibitor available. In Phase I of this SBIR study, a patented androgen receptor degradation enhancer, ASC-J9, has been demonstrated to be effective and safe in inducing regression of androgen-stimulated seborrhea in two different animal models for human acne. ASC-J9, a new chemical identity, is potentially superior to currently available medicines for acne treatment. AndroScience Corporation has committed substantial resources in developing ASC-J9 through the necessary regulatory approval process for evaluation as an anti-acne drug. In this Phase 2 application, we request support to complete critical development steps needed for Investigation of New Drug (IND) submission; precisely we are asking support for required regulatory studies related to drug substance scale-up, drug product formulation and manufacturing/quality control, as well as preclinical biosafety and bioefficacy testing. The acquired information will support AndroSciences effort to request approval from the Food and Drug Administration (FDA) to commence human clinical trials (Phase 3) and also help in securing follow-up funding or forming partnerships with established pharmaceutical companies to register the process necessary to bring a new drug to the marketplace. We believe that commercialization of an ASC-J9 topical cream will benefit public health by alleviating clinical symptoms in acne sufferers in a safer, and more effective and satisfactory fashion. ASC-J9 topical cream commercialization could replace some undesirable anti-acne drugs currently in use. Acnes are androgen-dependent. More effective, safer, and better-tolerated treatments for acnes are lacking. This project is designed to develop and eventually commercialize ASC-J9 topical cream as the first-in-class androgen inhibitor to accomplish the goal to alleviate clinical symptoms and achieve a higher degree of satisfaction in patients and doctors.

描述（由申请人提供）：痤疮是第二昂贵的皮肤病，每年的医疗支出为22.3亿美元。尽管整体健康没有受损，但痤疮可以产生一生的皮肤和情感疤痕。毫不奇怪的是，有很高的愿意支付痤疮治疗的意愿，而且市场预计将增长到120亿美元。目前，可用的药物主要用于治疗症状，并与严重的缺点（例如皮肤刺激）相关，需要长期治疗，致畸作用和抗生素耐药性。通过雄激素受体起作用以表达生物学反应的雄激素在痤疮的发展中起着重要作用，即疾病的原因。从理论上讲，使用雄激素受体抑制剂应诱导所有类型的痤疮症状缓解，更重要的是，干预从Comedones到更严重的，更严重的引起疤痕的炎症病变的进展。当前，尚无局部雄激素受体抑制剂。在这项SBIR研究的第一阶段，已证明获得专利的雄激素受体降解增强子ASC-J9在人类痤疮的两个不同动物模型中诱导雄激素刺激的急经症的回归是有效且安全的。 ASC-J9是一种新的化学身份，可能优于当前可用的痤疮治疗药物。 Androscience Corporation已通过必要的监管批准程序作为抗ACNE药物来开发ASC-J9，以开发ASC-J9。在此第2阶段申请中，我们要求支持新药（IND）提交所需的关键开发步骤；确切地说，我们正在寻求与药物量表，药物制剂和制造/质量控制以及临床前生物安全和生物效能测试有关的必需的调节研究。获得的信息将支持Androsciences的努力，要求获得食品药品监督管理局（FDA）开始人类临床试验（第3阶段），并有助于确保与已建立的制药公司建立后续资金或建立合作伙伴关系，以注册所需的过程，以注册所需的过程，以进行必要的过程。将新药带到市场。我们认为，ASC-J9局部霜的商业化将通过以更安全，更有效和令人满意的方式减轻痤疮患者的临床症状来使公共卫生受益。 ASC-J9局部奶油商业化可以替代目前正在使用的一些不良抗ACNE药物。痤疮依赖雄激素。缺乏对痤疮的更有效，更安全，更耐受的治疗方法。该项目旨在开发并最终将ASC-J9局部乳霜商业化为第一类雄激素抑制剂，以实现减轻临床症状并在患者和医生中获得更高程度满意度的目标。