Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy

TASIS-花生（皮肤内靶向过敏原特异性免疫疗法）贴剂治疗花生过敏的安全性和耐受性

• 批准号: 10551184
• 负责人: Samirkumar Patel
• 金额: $ 29.98万
• 依托单位: MOONLIGHT THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-10 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10551184
• 关键词: Accidents; Adult; Adverse reactions; Affect; Age; Agreement; Allergens; Allergic; Allergy to peanuts; Anaphylaxis; Cessation of life; Child; Clinic; Clinical; Clinical Trials; Collaborations; Critiques; Cutaneous; Data; Dendritic Cells; Dermal; Diet; Documentation; Dose; Equation; Europe; Evaluation; FDA approved; Family; Feedback; Food Hypersensitivity; Friends; Funding; Gills; Goals; Government; Grant; Hypersensitivity; Immune system; Immunotherapy; Investigation; Lead; Letters; Life; Malnutrition; Marketing; Mind; Miniature Swine; Mus; National Institute of Allergy and Infectious Disease; Needles; Painless; Pamphlets; Patients; Pediatric Hospitals; Pediatrics; Persons; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Phase III Clinical Trials; Population; Procedures; Production; Proteins; Protocols documentation; Quality of life; Reporting; Reproducibility; Research; Research Personnel; Risk Reduction; Running; Safety; Site; Skin; Small Business Innovation Research Grant; Statistical Data Interpretation; System; Technology; Therapeutic; Time; Universities; Visit; Work; clinical research site; desensitization; efficacy evaluation; first-in-human; immunoregulation; invention; medical schools; meetings; mid-career faculty; minimally invasive; mouse model; novel; novel therapeutics; peace; phase I trial; pre-clinical; preclinical development; programs; safety assessment; skin patch; social; trial planning

The following contains proprietary/privileged information that Moonlight Therapeutics requests not be released to persons outside the government, except for purposes of review and evaluation Safety and Tolerability of TASIS-Peanut (Targeted Allergen Specific Immunotherapy within the Skin) patch for the Treatment of Peanut Allergy Food allergies affect 30 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 is only one FDA approved therapy in the USA for food allergies. Food allergies are expected to grow 10% annually until at least 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. 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. Moonlight Therapeutics is developing a targeted way to administer allergens into the top skin layers to desensitize an allergic patient, called Targeted Allergen Specific Immunotherapy in the Skin (TASIS). Delivery is achieved using microneedles applied to the skin for a few minutes, which are minimally invasive and painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility. Because TASIS delivers small doses in the top and superficial skin layers, the approach is expected to produce little to no systemic adverse reactions. The company's first treatment is focused on peanut allergy and is called TASIS-Peanut. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization. This Fast-track (Phase1/Phase2) SBIR grant (U44) application is for a Phase 1 safety and tolerability study to be conducted in partnership between the company and collaborating clinical research sites. The objective of the U44 Fast- track grant is to prepare documents for (grant PHASE 1) and conduct (grant PHASE 2) a Phase 1 clinical trial to assess the safety and tolerability of TASIS-Peanut in peanut allergic children and adults. The Phase 2 portion of the grant also includes aims geared towards production of TASIS-Peanut for the clinical trial. The company currently has a R42 Fast-track grant for the pre-clinical development of TASIS-Peanut. Overall this grant will enable evaluation of the safety and tolerability of TASIS-Peanut in a first-in-human clinical trial. It will set the stage for evaluation of efficacy in a Phase 2 clinical trial.

以下内容包含 Moonlight Therapeutics 要求不得向政府以外人员透露的专有/特权信息，除非出于以下目的： 审查和评估 TASIS-Peanut（靶向过敏原特异性免疫疗法）的安全性和耐受性 用于治疗花生过敏的皮肤）贴剂 食物过敏影响美国 3000 万人和欧洲 1700 万人。美国有 600 万儿童，约占三分之一 至少有一种食物过敏；这相当于每个教室至少有 1 个。目前只有一种FDA批准 在美国治疗食物过敏。至少到 2022 年，食物过敏预计将以每年 10% 的速度增长。 一个人有不止一种过敏症是很常见的。这是一个不断增长、服务不足的全球市场，几乎没有得到治疗 选项。一种有意义的初始治疗是减少意外发生后发生过敏反应的机会 接触。这种疗法将有助于让家庭安心，让受食物过敏影响的儿童能够 更好的生活质量，减少被社会排斥的感觉，最重要的是减少意外死亡的可能性 程序。 Moonlight Therapeutics 正在开发一种有针对性的方法，将过敏原注入皮肤表层，从而使过敏原脱敏。 过敏患者，称为皮肤靶向过敏原特异性免疫疗法（TASIS）。交付是通过使用实现的 微针在皮肤上涂抹几分钟，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。因为 TASIS 在顶部输送小剂量 和浅层皮肤层，该方法预计不会产生全身不良反应。公司的 第一种治疗方法是针对花生过敏，称为 TASIS-Peanut。我们已经证明了我们的方法的有效性 花生致敏的临床前小鼠模型。 此快速通道（第一阶段/第二阶段）SBIR 拨款 (U44) 申请用于第一阶段安全性和耐受性研究 该研究是公司与合作临床研究中心合作进行的。 U44 Fast-的目标 跟踪拨款是为（拨款第 1 阶段）准备文件并进行（拨款第 2 阶段）第 1 阶段临床试验 评估 TASIS-Peanut 在花生过敏儿童和成人中的安全性和耐受性。第二阶段补助金部分 还包括生产用于临床试验的 TASIS-Peanut 的目标。公司目前拥有R42 TASIS-Peanut 临床前开发的快速通道资助。 总体而言，这笔赠款将能够在首次人体临床试验中评估 TASIS-Peanut 的安全性和耐受性。它将 为二期临床试验的疗效评估奠定基础。