This morning, Alladapt Immunotherapeutics — a private, clinical-stage biopharmaceutical company focused on the development of prescription therapeutics to address IgE-mediated food allergy — completed patient enrollment for its Phase 1/2 study of ADP101, its candidate intended to desensitize patients to one or more foods simultaneously in order to mitigate the risk of severe allergic reactions including anaphylaxis.
The trial, dubbed “Harmony”, is a double-blind, placebo-controlled Phase 1/2 study designed to evaluate the efficacy and safety of ADP101 in pediatric and adult patients diagnosed with an allergy to one or more of the foods represented in ADP101 which include: peanut, almond, hazelnut, cashew, pistachio, pecan, walnut, milk, egg, cod, salmon, shrimp, wheat, soy, and sesame. 73 participants drawn from 15 US sites have been enrolled, with nearly 75% reactive to as little as 1mg of an allergenic food.
Said Dr Ashley Dombkowski, Alladapt’s Chief Executive Officer and Co-Founder:
We are thrilled to report the completion of patient enrollment in our ongoing Phase 1/2 study of ADP101 and are encouraged by the outpouring of interest from the patient and physician community in the trial. Harmony swiftly and successfully enrolled a diverse group of adult and pediatric patients with a broad range of mono- and multi-food allergies, reflecting real-world patient profiles and demographics.
With ADP101, our research goal is to advance development of a drug candidate with the potential to become the first FDA-approved oral product able to simultaneously treat patients highly reactive to foods in the nine major food groups associated with food allergic reactions, including, and extending beyond, peanut allergy. Alladapt’s ADP101 formulation and the Harmony dosing protocol are based on intellectual property and scientific research including an extensive foundational therapeutic data package licensed to Alladapt from the laboratory of our co-founder, Kari Nadeau, M.D., Ph.D. As an allergist, clinician and protein biochemist, Dr. Nadeau pioneered multi-allergen oral immunotherapy both for use as stand-alone therapy and for use with adjunctive injectable immunomodulators. We look forward to reporting top-line data approximately one year from now.
Said Dr Dana McClintock, Alladapt Chief Medical Officer:
Constant, meticulous avoidance of food allergens is challenging and highly burdensome, particularly in patients with multiple food allergies. Accidental exposures occur, often in unexpected, difficult-to-manage settings like airplanes or schools. Our focus is to alleviate the burden of food allergy by advancing a comprehensive OIT with a flexible, low-and-slow up-dosing protocol designed to raise the threshold of reactivity by retraining the maladaptive food allergic immune response. We are thankful for the food allergy patients, their families, the investigators and the study site personnel who have made this study possible.
Additional information about the Phase 1/2 Harmony trial is available at clinicaltrials.gov (NCT04856865).