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: 10368182
• 负责人: Samirkumar Patel
• 金额: $ 93.44万
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10368182
• 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; 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治疗花生过敏 食物过敏影响美国 1500 万人和欧洲 1700 万人。六百万儿童，大约三分之一， 在美国至少有一种食物过敏；这相当于每个教室至少有 1 个。目前，没有 世界各地已批准治疗食物过敏的疗法。食物过敏预计每年增加 10% 直到 2022 年。一个人患有多种过敏症也很常见。这是一个不断增长、服务不足的 全球市场几乎没有治疗选择。一种有意义的初始治疗是减少 意外接触后有可能发生过敏反应。根据调查，过敏症专家和患者认为 减少因意外接触而发生过敏反应的机会的治疗是有意义的，并且 值得的。这种疗法将有助于让家庭安心，让受食物影响的儿童也能安心 过敏是为了获得更好的生活质量，减少被社会排斥的感觉，最重要的是减少过敏的可能性 因意外手术而死亡。每个患者每年的医疗负担大约为 3,000-4,000 美元。 Moonlight Therapeutics 正在开发一种有针对性的方法，将花生过敏原注入皮肤表层， 使过敏患者脱敏。分娩是通过微针实现的，这是一种微创且 无痛。重要的是，微针可以高精度和可重复性地输送到最表层皮肤。 由于递送是在顶部和浅表皮肤层，因此该方法预计几乎不会产生任何效果。 全身不良反应。我们已经在临床前小鼠模型中证明了我们的方法的有效性 花生过敏。在这份 STTR 快速通道拨款申请中，Moonlight Therapeutics 提出了以下目标： 将允许其向 FDA 提交研究性新药 (IND) 申请，进行首次人体试验。同相 1、提出了四个目标来开发生产花生过敏原蛋白和包被微球的工艺 严格的质量保证和操作程序，可以转移到 cGMP 生产。一功效 第一阶段还提出了动物研究。适当的里程碑和成功标准已经确定 为第一阶段设立。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，并根据 cGMP 建立生产。此外，动物研究将 这样做是为了将微针与传统的皮肤贴片进行比较。第二阶段结束时 IND 申请 将提交给FDA。 总的来说，这些研究将为支持新型、更安全的花生的开发提供基础 过敏免疫疗法治疗。