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.

以下内容包含专有/特权的信息，除非出于目的 审查和评估 TASIS-PEANUT的安全性和耐受性（靶向过敏原特异性免疫疗法 皮肤）用于治疗花生过敏的补丁 食物过敏会影响美国的3000万人，在欧洲影响1700万人。在美国，有600万儿童，大约13分之一 至少有一种食物过敏；这在每个教室中至少等于1个。目前，只有一个FDA批准 美国食物过敏的治疗。食物过敏预计每年将每年增长10％，直到至少2022年。 对于某人患有多种过敏的人常见。这是一个不断增长的全球市场，几乎没有治疗 选项。有意义的初始疗法将是一种偶然的过敏反应的机会 接触。这种疗法将有助于使家庭安心，让受食物过敏影响的儿童拥有 更好的生活质量，在社交上降低了铸造，最重要的是降低了意外死亡的潜力 程序。 Moonlight Therapeutics正在开发一种有针对性的方法，将过敏原施用到顶部皮肤层中，以使脱敏 过敏患者，称为皮肤（TASIS）的靶向过敏原特异性免疫疗法。使用 微孔系在皮肤上施加了几分钟，它们的侵入性微不足道且无痛。重要的是微针 可以以高精度和可重复性的形式递送到最高的皮肤层。因为塔西斯在顶部提供小剂量 和浅表皮层，预计该方法几乎不会产生全身性不良反应。公司的 首次治疗的重点是花生过敏，被称为TASIS-PEANUT。我们已经证明了我们的方法的功效 花生敏化的临床前小鼠模型。 此快速轨道（阶段1/阶段2）SBIR赠款（U44）应用于1阶段的安全性和耐受性研究 与公司与合作临床研究网站之间的合作伙伴关系。 u44 fast的目标 Track Grant是为（授予第1阶段）准备文件，并进行（授予第2阶段）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。赠款的第二阶段部分 还包括针对临床试验的Tasis-peanut生产的目标。该公司目前有R42 tasis-peanut临时发展的快速拨款。 总体而言，这笔赠款将使TASIS-PEANUT在人类的第一个临床试验中评估Tasis-Peanut的安全性和耐受性。会 在第二阶段临床试验中为评估功效的评估奠定了基础。