Berger William E, Faris Nicole, Weinstein Mark, Wilding Gregory E, Berglund Erick
Allergy & Asthma Solutions, Coto de Caza, California.
53nhealth.com, Richland, Washington.
Ann Allergy Asthma Immunol. 2025 Apr;134(4):448-456. doi: 10.1016/j.anai.2025.01.013. Epub 2025 Jan 20.
Oral mucosal immunotherapy (OMIT) involves the use of a specifically formulated toothpaste to deliver allergenic proteins to immunologically active areas of the oral cavity. This represents a novel delivery mechanism with several features designed to improve food allergy desensitization. OMIT has advantages over other approaches to allergy immunotherapy due to its targeted delivery and simplified administration.
To determine the safety, tolerability, and adherence to OMIT with INT301 in adults with peanut allergy.
The Oral Mucosal Escalation Goal Assessment study enrolled 32 adults, aged 18 to 55 years, with peanut allergy in a 3:1 ratio to receive either an escalating dose of INT301 or a placebo. Entry criteria included a positive skin prick test result with a wheal diameter greater than or equal to 3 mm than control and/or peanut-specific IgE level greater than or equal to 0.35 kU/L. Subjects were required to fail an oral food challenge less than or equal to 100 mg dose of peanut protein. Safety and tolerability were monitored in the 48-week trial period.
All active subjects (100%) tolerated the prespecified protocol at the highest dose. No moderate or severe systemic reactions were observed in the active participants. Nonsystemic adverse reactions were mostly local (oral and nasal cavities), mild and transient. Active subjects adhered to the treatment for 97% of the days in the study, with no withdrawals due to study medication.
In the Oral Mucosal Escalation Goal Assessment trial, INT301 met all primary and secondary end points of safety, tolerability, and adherence. Thus, OMIT seems to be a safe and convenient option for individuals with food allergies. These results support the need for further evaluation in the pediatric population.
ClinicalTrials.gov Identifier: NCT04603300.
口腔黏膜免疫疗法（OMIT）是指使用一种特殊配方的牙膏将变应原蛋白递送至口腔的免疫活性区域。这代表了一种新型的递送机制，具有多项旨在改善食物过敏脱敏效果的特性。由于其靶向递送和给药方式简便，OMIT相较于其他过敏免疫疗法具有优势。
确定INT301用于花生过敏成人患者的口腔黏膜免疫疗法的安全性、耐受性和依从性。
口腔黏膜递增目标评估研究纳入了32名年龄在18至55岁之间的花生过敏成人，按照3:1的比例分别接受递增剂量的INT301或安慰剂。入选标准包括皮肤点刺试验结果为阳性，风团直径比对照大或等于3毫米，和/或花生特异性IgE水平大于或等于0.35 kU/L。受试者需在口服食物激发试验中对小于或等于100毫克剂量的花生蛋白不耐受。在48周的试验期内监测安全性和耐受性。
所有活性组受试者（100%）均耐受最高剂量的预定方案。活性组参与者未观察到中度或重度全身反应。非全身不良反应大多为局部（口腔和鼻腔）、轻度且短暂。活性组受试者在研究中97%的天数坚持治疗，无因研究药物而退出的情况。
在口腔黏膜递增目标评估试验中，INT301达到了安全性、耐受性和依从性的所有主要和次要终点。因此，对于食物过敏个体而言，口腔黏膜免疫疗法似乎是一种安全且便捷的选择。这些结果支持在儿科人群中进行进一步评估的必要性。
ClinicalTrials.gov标识符：NCT04603300。
