By Joe Gorelick, MSN, FNP-C

The ability to treat food allergy with oral immunotherapy could be closer to clinical reality. The FDA has granted Fast Track Designation for ADP101, an investigational multi-food oral immunotherapy (mOIT) from Alladapt Immunotherapeutics, Inc.

Dermatology care professionals recognize the importance of intervention for food allergy, given the association of food allergy with eczema. In fact, food allergy is among the most common and potentially serious comorbidities associated with atopic dermatitis.  Upon FDA approval we will have several practical considerations. Specifically, we will want to determine if there will be consequences for patients that are on existing biologic and small molecule therapy that may inhibit immunotherapeutic agents from exerting the desired effect.

Alladapt says ADP101 is the most advanced multi-food OIT pharmaceutical candidate in development. The product is intended as a treatment for food allergy, including the simultaneous treatment of multiple food allergies and the treatment of single food allergies, in children (4-17 years of age) with confirmed allergy to one or more of the following 15 foods contained in the drug product: almond, cashew, chicken egg, codfish, cow milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut and wheat.

Fast Track Designation allows more frequent meetings and written communications with FDA to discuss the drug’s development plan, clinical trial design, and data collection. Fast Track designated drugs can take advantage of Rolling Review and are also eligible for Priority Review if relevant criteria are met.

The Fast Track designation for ADP101 was supported by results from Alladapt’s Phase 1/2 Harmony trial, which were presented at the 2023 European Academy of Allergy & Clinical Immunology Congress and the 2023 American College of Allergy, Asthma, and Immunology Annual Meeting. In the trial, ADP101 generated dose-dependent, clinically meaningful responses as a multi-OIT food allergy desensitization therapy, with a favorable safety and tolerability profile in pediatric patients allergic to one or more of the food sources in the product. Alladapt is conducting the Encore Study, an open-label extension study of the Harmony study assessing long term use of ADP101 in mono- and multi-food allergic patients.