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.

针靶向变应原特异性免疫治疗花生过敏的研究 食物过敏影响着美国1500万人和欧洲1700万人。600万名儿童，大约每13人中就有1人， 在美国，至少有一个食物过敏;这相当于每个教室至少有一个。目前没有 食物过敏的治疗方法。食物过敏预计每年增长10% 直到2022年它也是常见的人有一个以上的过敏。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。一个有意义的初始治疗将是一个减少 意外暴露后过敏反应的可能性。根据调查，过敏症专家和患者认为， 减少意外暴露引起过敏反应的可能性的治疗是有意义的， worthwhile.这种疗法将有助于给家庭带来心灵的平静， 过敏症有更好的生活质量，感觉不那么社会排斥，最重要的是减少潜在的 意外手术死亡。每位患者每年的医疗负担约为3，000 - 4，000美元。 月光治疗公司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， 使过敏病人脱敏使用微针实现递送，微针是微创的， 无痛的重要的是，微针可以以高精度和可重复性递送到最顶层的皮肤层中。 因为输送是在顶部和浅表皮肤层，该方法预计将产生很少或没有 全身不良反应。我们已经证明了我们的方法在临床前小鼠模型中的有效性。 花生致敏在这个STTR快速通道赠款申请月光治疗提出的目标， 将允许它向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用于生产花生过敏原蛋白质和用以下物质包被的MN的方法： 严格的质量保证和操作程序，可以转移到cGMP生产。疗效 在第1阶段中还拟定了动物研究。适当的里程碑和成功标准已经 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，并在cGMP下建立生产。此外，动物研究将 是为了比较微针和传统的皮肤贴片。在第2阶段结束时，IND申请 将提交给FDA。 总的来说，这些研究将为支持开发一种新型和更安全的花生提供基础。 过敏免疫治疗