FDA Grants Fast Track Designation to Investigational Food Allergy Immunotherapy


The FDA granted Fast Track Designation to ADP101 based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies.

The FDA has granted Fast Track Designation to ADP101 (Alladapt Immunotherapeutics, Inc.), a novel, multi-food oral immunotherapy in development for the treatment of allergies to one or more food allergens. In a press release, Alladapt Immunotherapeutics said the investigational drug is the most advanced multi-food oral immunotherapy drug candidate currently in development.1

Image credit: bit24 | stock.adobe.com

Image credit: bit24 | stock.adobe.com

“The FDA’s decision to grant ADP101 Fast Track Designation signifies an important milestone for people suffering from the substantial burden of food allergy, which requires constant, meticulous avoidance of all consumption or contact with allergens,” said Alladapt CEO and co-founder Ashley Dombkowski, PhD, in a statement.1

ADP101 is being developed for food allergies in individuals from 4 to 17 years of age with a confirmed allergy to one or more of the following foods: almond, cashew, chicken egg, codfish, cow milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat.1 To date, the FDA has not approved any oral immunotherapies for multi-food allergy or for food allergies other than for a peanut allergy.

An independent study found that over a 12-month period, 93% of individuals who sought treatment in the emergency department for allergic reactions were for either multi-allergic reactions or allergic reactions to foods other than peanut, with just 6.6% of individuals only being allergic to peanuts. Alladapt noted that this finding emphasizes the importance of developing a treatment for multiple allergens.1

The FDA granted Fast Track Designation based on findings from the phase 1/2 Harmony trial (NCT04856865), which analyzed the safety and efficacy of the novel treatment in desensitizing patients with single or multiple food allergies. The trial results, which were presented at the 2023 European Academy of Allergy and Clinical Immunology Congress and the 2023 American College of Allergy, Asthma, and Immunology Annual Meeting, showed ADP101 produced dose-dependent and clinically meaningful responses. The drug was also found to have a favorable safety and tolerability profile in pediatric patients who are allergic to one or more food sources.1

In data from pediatric patients, desensitization to 600 mg or more protein from one or more qualifying allergens at 40 weeks was found to be 55% in patients administered high-dose ADP101, 38.1% in patients administered low-dose ADP101, and 20% in those given a placebo. Further, desensitization to two or more foods at the 600 mg of protein or higher threshold was found to be 55.6% in the high-dose ADP101 cohort, 22.2% in the low-dose cohort, and 0% with placebo, whereas desensitization to two or more foods at the 1000 mg or higher threshold was observed in 44.4%, 11.1%, and 0%, respectively.2

The majority of treatment-emergent adverse events (AEs) were deemed mild or moderate, primarily occurring during the up-dosing treatment period. There were no AEs observed in the dose-maintenance phase with a frequency of >15% in any treatment cohort. Further, there were no severe anaphylactic events or discontinuations for anaphylaxis attributed to the study drug, as well as no evidence for treatment-associated sensitization to new allergens during the trial.2

“Based on these Harmony data, we are now looking ahead to a phase 3 program to support regulatory approval of ADP101,” said Dana McClintock, MD, Alladapt’s chief medical officer, in a press release prior to the 2023 EAACI Congress. “Food allergy is a largely invisible, chronic disease that places a severe immunological and psychological burden on patients and their families. With limited treatment options, clinicians are actively seeking effective, practical interventions that could be broadly accessed by as many of their patients as possible. As we progress our clinical program, we intend to continue partnering with the food allergy community to ensure these needs are well reflected in our program.”2


1. Alladapt Immunotherapeutics Receives FDA Fast Track Designation for ADP101 for the Treatment of Mono- and Multi-Food Allergies. GlobeNewswire. November 22, 2023. Accessed November 27, 2023. https://www.globenewswire.com/en/news-release/2023/11/22/2784744/0/en/Alladapt-Immunotherapeutics-Receives-FDA-Fast-Track-Designation-for-ADP101-for-the-Treatment-of-Mono-and-Multi-Food-Allergies.html

2. Alladapt Immunotherapeutics Announces Topline Pediatric Data from Phase 1/2 Harmony Study Evaluting ADP101 for the Treatment of Patients with Mono- and Multi-Food Allergy, as Presented at the European Academy of Allergy and Clinical Immunology Hybrid Congress. News release. June 13, 2023. Accessed November 27, 2023. https://assets-global.website-files.com/5e4aeee404e0b868e6d9f7f0/6487b687b908c9bf3498a537_Alladapt%20%E2%80%93%C2%A0EAACI%20%E2%80%93%2013-JUN-2023.pdf

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