Use of single-allergen oral immunotherapy (OIT) in patients with food allergies is limited by the need for multiple products and the time spent in sequential rounds of therapy for those with multiple allergies. Enhanced treatment options for these patients are needed. ADP101 is a multiallergen OIT in development to treat allergy spanning the 9 major food allergen groups. ADP101 is a mixture of equal parts by protein weight of allergenic proteins from 15 foods (ie, almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame, shrimp, soy, walnut, wheat). The Phase 1/2 Harmony trial (NCT04856865) is a randomized, double blind, placebo-controlled trial currently underway to evaluate the efficacy and safety of ADP101 for inducing desensitization in patients with single or multiple food allergies.

Eligible patients were aged 4 to 55 years and had a qualifying food allergy to 1-5 foods contained in ADP101, defined as dose-limiting symptoms on exposure to ≤100 mg on double-blind, placebo-controlled food challenge (DBPCFC) at screening. Nonqualifying foods were those eliciting a reaction at >100 mg but ≤1000 mg on DBPCFC. Patients were randomized to either a low-dose (1500 mg/day) or high-dose (4500 mg/day) regimen of either ADP101 or matched placebo, which included an initial up-dosing phase followed by a maintenance phase. The primary efficacy measure is the response rate, which is defined as the proportion of patients who tolerate ≥600 mg of ≥1 qualifying food without dose-limiting symptoms on exit DBPCFC. Exploratory analyses will evaluate whether allergy to nonqualifying foods responds to treatment with ADP101.

A total of 109 patients were screened across 16 US clinical sites, and 73 patients with single or multiple food allergies were enrolled between April-December 2021. Most participants were children (per protocol), had multiple food allergies, and had a history of anaphylaxis (Table). All 15 targeted allergens contained in ADP101 are represented as qualifying food allergies in the study cohort. Eliciting doses ranged from 1 to 100 mg, and aggregated nonpeanut allergens presented with slightly lower eliciting doses than peanut allergen (Figure). About one-third of patients had nonqualifying food allergy. 

The Harmony trial will evaluate the potential of ADP101 as a multiallergen OIT to simultaneously treat patients with one or more food allergies.