Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies

基于微针的靶向过敏原特异性免疫疗法治疗花生过敏

• 批准号: 9899934
• 负责人: Samirkumar Patel
• 金额: $ 29.78万
• 依托单位: MOONLIGHT THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9899934
• 关键词: Adverse reactions; Affect; Allergen Immunotherapy; Allergens; Allergic; Allergy to peanuts; Anaphylaxis; Animals; Applications Grants; Cessation of life; Child; Cyclic GMP; Development; Europe; Family; Food Hypersensitivity; Foundations; Healthcare; Hypersensitivity; Immunotherapy; Investigational New Drug Application; Mind; Painless; Patients; Phase; Procedures; Process; Production; Proteins; Quality of life; Reproducibility; Skin; Small Business Technology Transfer Research; Surveys; Therapeutic; Toxic effect; base; cGMP production; desensitization; efficacy study; first-in-human; good laboratory practice; minimally invasive; mouse model; novel; peace; pre-clinical; quality assurance; skin patch; social; success

Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies Food allergies affect 15 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there are no approved therapies for food allergies anywhere in the world. Food allergies are expected to grow 10% annually until 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Based on surveys, allergists and patients believe a therapy that reduces the chance for anaphylactic reaction from accidental exposure is meaningful and worthwhile. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. The approximate healthcare burden per patient is $3,000-4,000 per year. Moonlight Therapeutics is developing a targeted way to administer peanut allergens into the top skin layers to desensitize an allergic patient. Delivery is achieved using microneedles, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because the delivery is in top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. In this STTR Fast-Track grant application Moonlight Therapeutics has proposed aims that will allow it to file an investigational new drug (IND) application with the FDA for first-in-human trials. In Phase 1, four aims are proposed to develop processes for producing peanut allergen proteins and coated MNs with strict quality assurance and operating procedures that can be transferred to cGMP production. An efficacy study in animals is also proposed in Phase 1. Appropriate milestones and success criteria have been established for Phase-1. In Phase-2, four aims are proposed so as to perform non-GLP (good laboratory practices) and GLP toxicity studies, and establish production under cGMP. In addition, animal studies will be done to compare microneedles to a conventional skin patch. At the conclusion of Phase-2 an IND application will be submitted to the FDA. Overall, these studies will provide the foundation to support the development of a novel and safer peanut allergy immunotherapy treatment.

微针导向变应原特异性免疫疗法治疗花生过敏 食物过敏影响着美国的1500万人和欧洲的1700万人。600万儿童，大约每13人中就有1人， 在美国，至少有一种食物过敏；这相当于每个教室至少有一种。目前，没有 世界上任何地方都批准了食物过敏的疗法。食物过敏症预计每年增长10% 直到2022年。一个人有不止一种过敏症也是很常见的。这是一个不断增长的，服务不足的 全球市场，几乎没有治疗选择。一个有意义的初步治疗将是一种减少 意外接触后发生过敏反应的机会。根据调查，过敏症专科医生和患者认为 减少意外暴露引起过敏反应的机会的治疗是有意义的 值得一试。这样的疗法将有助于给家庭带来安心，允许受食物影响的儿童 过敏可以改善生活质量，减少被社会排斥的感觉，最重要的是减少潜在的 意外程序导致的死亡。每个患者每年的医疗负担约为3,000-4,000美元。 Moonlight Treateutics正在开发一种有针对性的方法，将花生过敏原注射到皮肤表层，以 使过敏病人脱敏。分娩是使用微针实现的，微针具有微创和 没有痛苦。重要的是，微针可以以高精度和重复性进入最上层的皮肤。 由于给药是在表层和浅层，这种方法预计不会产生什么效果。 全身不良反应。我们已经在临床前的小鼠模型中证明了我们的方法的有效性。 花生敏化。在这项STTR快速通道拨款申请中，月光治疗公司提出了以下目标 将允许它向FDA提交试验性新药(IND)申请，进行首次人体试验。同相 1、提出了花生变应原蛋白生产工艺的四个目标，并对花生变应原蛋白进行了包衣处理。 严格的质量保证和操作规程，可转移到cGMP生产。一种功效 在第一阶段也提出了动物研究。适当的里程碑和成功标准 为第一阶段建立的。在第二阶段，提出了四个目标，以执行非GLP(良好实验室 实践)和GLP毒性研究，并在cGMP下建立生产。此外，动物研究将是 这样做是为了将微针与传统皮肤贴片进行比较。在第二阶段IND应用程序结束时 将提交给FDA。 总体而言，这些研究将为开发一种新的、更安全的花生提供基础 变态反应免疫疗法治疗。