The US Food and Drug Administration (FDA) has granted a fast track designation to Alladapt Immunotherapeutics’ IgE-mediated multi-food oral immunotherapy ADP101.
The FDA’s decision was based on the results from the Phase I/II Harmony trial, which investigated the immunotherapy’s use in inducing desensitisation in patients with single or multiple food allergies, including nuts, dairy, seafood and more.
Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling and priority reviews.
In this instance the designation allows Alladapt to seek accelerated approval for oral immunotherapy in paediatric patients, aged between four and 17 years, with one or more of the 15 food allergies covered by ADP101, as per a 22 November press release.
Phase I/II data
The double-blind, placebo-controlled Phase I/II Harmony trial (NCT04856865) enrolled 61 paediatric patients (aged four-17 years) and 12 adult patients (aged 18-55 years).
The trial met its primary endpoint with 55% of the paediatric participants being able to tolerate at least 600mg of protein from one or more qualifying foods without dose-limiting symptoms in the ADP101 treatment group compared to the 20% of the placebo group.
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In the ADP101 group, 56% of the multi-allergic participants demonstrated simultaneous desensitisation to 600mg or more of protein from two or more food allergens with a high dose of oral immunotherapy compared to a 0% response rate in the placebo group.
Desensitisation to 1,000mg or more of protein from two or more food allergens was seen in 44% of the patients receiving high doses of ADP101, compared to a 0% response rate in the patients receiving placebo.
The oral immunotherapy was safe and well tolerated, with most adverse events being mild to moderate in severity. Furthermore, the rates of adverse events decrease as move from up-dosing to maintenance dosing.
In both the treatment and placebo groups, 5% of the participants discontinued the study due to adverse events. Alladapt was quick to add that “no study participants on ADP101 discontinued the study due to anaphylaxis”, as per a 9 November press release.
The Phase III trial for ADP101 is planned for initiation in 2024 and is expected to last for 12 months. The trial will evaluate the oral immunotherapy in paediatric patients aged four-17 years.
Food allergy treatment landscape
As per GlobalData analysis, the food allergy market is forecasted to be worth $2.7bn globally in 2030, with ViaSkin Peanut being the most profitable food allergy drug generating $1.3bn in sales by 2030.
GlobalData is the parent company of Clinical Trials Arena.
Most of the drugs currently in development for managing food allergy target peanut allergies specifically. DBV Therapeutic is currently conducting additional safety trials for the ViaSkin peanut skin patch after the FDA requested it before granting approval for the therapy. Intrommune Therapeutics is currently evaluating its toothpaste-delivered immunotherapy INT301 in a Phase I trial (NCT04603300).