Tuesday, April 16, 2024

FDA Grants Fast Track Designation to Alladapt’s ADP101 Multi-Food Allergy Treatment

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The FDA has awarded Fast Track Designation to ADP101, a groundbreaking oral immunotherapy for multi-food allergy developed by Alladapt Immunotherapeutics, Inc. This innovative treatment offers hope for individuals aged 4 to 17 with confirmed allergies to a range of foods, including almonds, cashews, eggs, milk, peanuts, and more.

Alladapt CEO Ashley Dombkowski, Ph.D., hailed the FDA’s decision as a crucial step forward for those burdened by the challenges of food allergies, emphasizing the need for effective therapies. ADP101 represents a significant advancement in the field, as there are currently no FDA-approved oral immunotherapies for multi-food allergies or allergies beyond peanuts.

A recent study found that the majority of emergency department visits for allergic reactions were due to multi-allergic reactions or allergies to foods other than peanuts, underscoring the importance of developing treatments for multiple allergens. The Fast Track Designation is based on promising results from the phase 1/2 Harmony trial, which assessed ADP101’s safety and effectiveness in desensitizing patients with single or multiple food allergies. The trial data, presented at key medical conferences, demonstrated that ADP101 produced clinically meaningful responses and exhibited a favorable safety profile in pediatric patients.

Fast Track Designation

ADP101 That Has Received Fast Track Designation, Shows Promise in Pediatric Food Allergy Treatment

Among pediatric patients, desensitization to one or more qualifying allergens at the 600 mg protein threshold was achieved in 55% of high-dose ADP101 recipients, 38.1% of low-dose recipients, and 20% of placebo recipients at 40 weeks. Furthermore, desensitization to two or more foods at the 600 mg protein threshold was observed in 55.6% of high-dose ADP101 patients, 22.2% of low-dose patients, and 0% of placebo patients. At the 1000 mg protein threshold, desensitization to two or more foods was achieved in 44.4%, 11.1%, and 0%, respectively.

Most treatment-related adverse events were mild or moderate, primarily occurring during the up-dosing phase, and there were no severe anaphylactic events attributed to the study drug or new sensitizations during the trial.

Alladapt is now preparing for a phase 3 program to support the regulatory approval of ADP101. With limited treatment options available for food allergies, the company aims to collaborate with the food allergy community to meet the needs of patients and their families effectively.

Resource: PharmExec, November 27, 2023

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