ADP101 multifood oral immunotherapy for food-allergic patients: Harmony phase 1/2 randomized clinical trial.

ABSTRACT:

Background

Oral immunotherapy is an established approach to desensitize the immune system in the context of allergic disease; however, the only currently approved product is for peanut allergy. ADP101 is a novel, pharmaceutical-grade, multifood oral immunotherapy in development to simultaneously treat single or multiple food allergies, containing allergenic proteins from 15 foods in equal parts by protein weight.

Objective

The phase 1/2 Harmony trial (NCT04856865) evaluated efficacy and safety of ADP101 in participants with qualifying allergy to 1 to 5 foods in ADP101, defined as dose-limiting symptoms with a ≤100 mg challenge dose during double-blind, placebo-controlled food challenge (DBPCFC).

Methods

Participants were randomized to low-dose (1500 mg/d; 100 mg prote

SUBMITTER: Kim EH 

PROVIDER: S-EPMC11786640 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature