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: 10407661
• 负责人: Samirkumar Patel
• 金额: $ 91.89万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10407661
• 关键词: Address; Adverse reactions; Advisory Committees; Affect; Allergen Immunotherapy; Allergens; Allergic; Allergy Shot; Allergy to peanuts; Anaphylaxis; Animals; Applications Grants; Capsid Proteins; Cessation of life; Child; Clinical Data; Cutaneous; Cyclic GMP; Development; Devices; Diet; Dose; Europe; FDA approved; Family; Family suidae; Feedback; Film; Food Hypersensitivity; Foundations; Gills; Goals; Grant; Healthcare; Hypersensitivity; Immunotherapy; Investigational Drugs; Investigational New Drug Application; Langerhans cell; Lead; Length; Life; Malnutrition; Medical; Mind; Mus; Painless; Patients; Persons; Phase; Phase I Clinical Trials; Phase II/III Clinical Trial; Play; Population; Procedures; Process; Production; Proteins; Published Comment; Quality of life; Reproducibility; Risk; Route; Safety; Skin; Small Business Technology Transfer Research; Subcutaneous Injections; Surveys; Technology; Testing; Texas; Therapeutic; Toxic effect; Toxicology; Translating; Universities; base; cGMP production; desensitization; efficacy study; efficacy validation; experience; first-in-human; good laboratory practice; human subject; immunoengineering; improved; in vivo; minimally invasive; mouse model; novel; peace; porcine model; pre-clinical; quality assurance; respiratory; skin patch; social; subcutaneous; success; technology development

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.

基于微针的靶向过敏原特异性免疫疗法，用于治疗花生过敏 食物过敏会影响美国的1500万人，欧洲影响1700万。 600万儿童，大约13分之一， 在美国，至少有一种食物过敏；这在每个教室中至少等于1个。目前，没有 批准的食物过敏的疗法。食物过敏预计每年增长10％ 直到2022年。某人患有多种过敏也很常见。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。有意义的初始疗法将是一种减少的疗法 意外暴露后过敏反应的机会。根据调查，过敏者和患者认为 减少因意外暴露而导致过敏反应的机会是有意义的，并且 值得。这种疗法将有助于使家人安心，允许食物影响的儿童 过敏以具有更好的生活质量，在社交上降低的过敏，最重要的是降低了潜力 意外程序死亡。每位患者的大约医疗保健负担为每年3,000-4,000美元。 Moonlight Therapeutics正在开发一种针对性的方法，将花生过敏原施用到顶部皮肤层 使过敏患者脱敏。使用微针的交付是微不足道的，这些微针很侵入性和 无痛。重要的是，微针可以具有高精度和可重复性的最高皮肤层。 由于递送在顶部和表面皮肤层，因此预计该方法几乎不会产生 全身不良反应。我们已经在临床前小鼠模型的模型中证明了方法的功效 花生敏化。在这个STTR快速训练应用程序应用程序中，Moonlight Therapeutics提出了目的 将允许其向FDA提出研究新药（IND），以进行首次人类试验。在阶段 1，提出了四个目标来开发生产花生过敏原蛋白和涂层MN的过程 严格的质量保证和操作程序可以转移到CGMP生产中。功效 在第1阶段还提出了动物研究。适当的里程碑和成功标准已经 为1阶段建立。在第2阶段，提出了四个目标以执行非GLP（良好的实验室 实践）和GLP毒性研究，并在CGMP下建立生产。此外，动物研究将是 将微针与传统的皮肤贴片进行比较。在第2阶段的结论结束时 将提交给FDA。 总体而言，这些研究将为支持新颖，更安全的花生的发展提供基础 过敏免疫治疗。