Alladapt Immunotherapeutics, Inc., announced that ADP101, its investigational multi-food oral immunotherapy (mOIT) designed to simultaneously treat allergy to one or more of the world’s most significant food allergens, received Fast Track Designation from the FDA. ADP101 is the most advanced multi-food OIT pharmaceutical candidate in development.
There are currently no FDA-approved OIT treatments for multi-food allergy or for allergy to foods other than peanut. In an independent study of patients who sought treatment for food allergic reactions in the emergency department over a 12-month period, 93% were either multi-allergic or allergic to foods other than peanut, with only 6.6% allergic to peanut alone.1 This amplifies the need for interventions that can target a breadth and depth of allergens.
The Fast Track Designation grant letter provides FDA endorsement for expedited development of ADP101 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.
FDA’s Fast Track program is designed to expedite the development of new drugs intended to treat serious or life-threatening conditions. Fast Track 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, wherein a company can submit completed sections of its Biologic License Application (BLA) for review by FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. Such drugs are also eligible for Priority Review, if relevant criteria are met. This designation aims to bring important new drugs to patients earlier and address unmet medical needs.
The Fast Track designation for ADP101 was supported by results from Alladapt's Phase 1/2 Harmony trial (NCT04856865) evaluating the efficacy and safety of ADP101 for inducing desensitization in patients with single or multiple food allergies. Study results presented at the 2023 European Academy of Allergy & Clinical Immunology Congress and the 2023 American College of Allergy, Asthma, and Immunology Annual Meeting demonstrated that 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 also 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.
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