FDA Grants Fast Track Status to Oral Immunotherapy for Multiple Food Allergies

The Food and Drug Administration (FDA) has granted Fast Track designation to ADP101 for the treatment of 1 or more of the most significant food allergens.

ADP101 is an investigational multi-allergen oral immunotherapy designed to simultaneously treat allergy to the following food allergens: almond, cashew, chicken’s egg, codfish, cow’s milk, hazelnut, peanut, pecan, pistachio, salmon, sesame, shrimp, soy, walnut, and wheat.

The designation is supported by efficacy and safety data from the phase 1/2 Harmony trial (ClinicalTrials.gov Identifier: NCT04856865). Treatment with ADP101 demonstrated clinically meaningful, dose-dependent responses in 61 pediatric patients with mono- and multi-food allergies. As for safety, ADP101 was well tolerated with most adverse events being mild to moderate in severity. Patients on active therapy were primarily treated with epinephrine during up-dosing for the management of mild or moderate reactions.

The Company is also investigating ADP101 in the Encore study (ClinicalTrials.gov Identifier: NCT05243719), an open-label extension study of the Harmony study.

Ashley Dombkowski, PhD, CEO and Co-Founder of Alladapt, said, “The FDA’s decision to grant ADP101 Fast Track Designation signifies an important milestone for people suffering from the substantial burden of food allergy, which requires constant, meticulous avoidance of all consumption or contact with allergens. Our team is thrilled to be at the forefront of developing a new treatment that addresses such a huge unmet need. We are excited to collaborate even more closely with the FDA as we move ahead to expedite development of this important therapy.”