The Fast Track Designation follows the recent announcement of phase 1/2 data from the Harmony trial.
Alladapt Immunotherapeutics has announced its lead product candidate ADP101, an oral immunotherapy (OIT) representing 9 food groups, has received Fast Track Designation from the FDA following positive results from a phase 1/2 trial (NCT04856865) featuring pediatric patients.1
Currently, there are no FDA-approved OIT treatments for multi-food allergy to foods other than peanut. According to Alladapt, an independent study of patients seeking treatment for food allergic reactions in the emergency department setting over a 12-month period was conducted. In the study, 93% of patients were multi-allergic or allergic to foods other than peanut.1
The Fast Track Designation was supported by results from the Phase 1/2 Harmony trial, which evaluated efficacy and safety of ADP101 and its ability to induce desensitization in patients with single or multiple food allergies.1
ADP101 is designed to treat allergy to 1 or more of the world’s most significant allergens including cashew, almond, chicken’s egg, cow’s milk, codfish, peanut, pecan, pistachio, salmon, sesame, soy, shrimp, walnut and wheat, Alladapt stated in a press release.2
Results were presented at the 2023 American College of Allergy, Asthma, and Immunology Annual Meeting. Results demonstrated ADP101 generated dose-dependent and clinically meaningful responses. A favorable safety and tolerability profile in pediatric patients was observed for those allergic to 1 or more food sources in the product.1,2
Clinically meaningful, dose-dependent responses were reported in 61 pediatric patients with mono- and multi-food allergies. The primary outcome was the proportion of participants tolerating a single dose of at least 600 mg of protein from qualifying foods without dose-limiting symptoms.2
These symptoms were recorded via a double-blind, placebo-controlled food challenge at study exit.2
The intent-to-treat population revealed 55% of patients that received high-dose ADP101 experienced desensitization compared to 20% in the placebo group.2
Additional efficacy was demonstrated through secondary outcomes, as 56% of multi-allergic patients in the high-dose arm achieved simultaneous desensitization to 600 mg or more of protein from 2 or more food allergens. This is compared to a 0% response rate among patients receiving placebo.2
Forty-four percent of patients that received high-dose ADP101 were desensitized to 1000 mg or more of protein from 2 or more food allergens compared to 0% response rate from patients that received placebo.2
“The Harmony data is notable for several reasons. First, the diversity of disease presentation was remarkable, with 31 unique food allergen combinations confirmed among the 61 pediatric patients in the study,” said Warner Carr, MD, allergist, Allergy & Asthma Associates of Southern California, and primary investigator of the Harmony study.2
“Next, the safety and tolerability data were strong as evidenced by a study discontinuation rate due to adverse events of just 5% – a rate that was indistinguishable from the rate seen in placebo patients and well below rates commonly reported in the literature for other OIT protocols. Finally, the efficacy analysis was promising; after less than a year on therapy, 56% of multi-allergic patients were simultaneous responders across two or more food allergies compared to none on placebo. Based on these results, ADP101 has the potential to transform the value proposition of oral immunotherapy for the treatment of food allergy and expand the patient population that could be treated.”2
According to the press release, Alladapt is preparing for a phase 3 study of ADP101 in 2024.2
1. Alladapt Immunotherapeutics receives FDA Fast Track Designation for ADP101 for the treatment of mono- and multi-food allergies. Alladapt Immunotherapeutics. Press release. November 22, 2023. Accessed November 22, 2023.
2. Alladapt Immunotherapeutics presents phase 1/2 harmony data demonstrating therapeutic potential and safety of ADP101 for the treatment of food allergy at 2023 ACAAI Annual Meeting. Alladapt Immunotherapeutics. Press release. November 9, 2023. Accessed November 22, 2023.