Oral immunotherapy (OIT) is an established approach to desensitizing patients with food allergies. Today, there is only one FDA-approved OIT treatment (Palforzia), and it only treats peanut allergy.
ADP101 is a novel, pharmaceutical-grade OIT candidate from Alladapt Immunotherapeutics intended to treat single or multiple food allergies to 15 common allergenic foods simultaneously.
The Phase 1/2 Harmony trial evaluated the efficacy and safety of ADP101 in participants with allergies to 1 to 5 foods, defined as dose-limiting symptoms with a ≤100 mg challenge dose during double-blind, placebo-controlled food challenge (DBPCFC).
61 pediatric patients aged 4-17 were split into three cohorts: Low-Dose ADP (100mg protein per food), High-Dose ADP (300mg per food) and placebo with dose escalation and maintenance completed over 40 weeks. The participants then received a DBPCFC to determine whether they had reached the primary endpoint of tolerating ≥600 mg challenge dose of a single qualifying food without dose-limiting symptoms.
A greater response rate was observed in both the high-dose ADP101 (55.0%) and low-dose ADP101 (38.1%) groups compared with pooled placebo (20.0%) while desensitization to ≥2 foods was observed in individuals with multiple food allergies, as was desensitization at levels over 600 mg.
ADP101-treated participants showed an overall reduction in skin-prick test reactivity, with an increase in maximum tolerated dose across the majority of foods tested. Adverse events were mostly mild or moderate, with no life-threatening events or deaths.
Although the study fell short of its primary endpoint, the researchers concluded ADP101 increased the reactive threshold in pediatric participants with single or multiple food allergies across multiple endpoints while displaying a favorable safety profile, warranting further clinical investigation.
