ADP101 is an oral immunotherapy to treat multi-food and single-food allergies
Alladapt Immunotherapeutics has announced that its investigational multi-food oral immunotherapy (mOIT), ADP101, has received Fast Track Designation from the US Food and Drug Administration (FDA).
The designation will endorse the development of ADP101 as a treatment for some of the world’s most significant food allergens.
The FDA-designated product will allow Alladapt to develop ADP101 as a treatment for multi-food allergies and single food allergies in children aged four to 17 years old with a confirmed allergy to one or more of the 15 foods specified in the drug product, including almond, cashew, salmon and wheat.
An independent study revealed that 93% of patients who sought treatment for food allergic reactions in the emergency department across 12 months were multi-allergic or allergic to foods other than peanut.
The decision was based on results from Alladapt’s phase 1/2 Harmony trial to evaluate the safety and efficacy of ADP101 for inducing desensitisation in patients with single or multi-food allergies.
The results demonstrated that the treatment generated dose-independent and clinically meaningful responses as a multi-OIT food and allergy desensitisation therapy.
Additionally, the company conducted the Encore Study, an open-label extension of the Harmony study, to evaluate the long-term use of ADP101 in mono- and multi-food allergic patients.
FDA Fast Track-designated drugs are able to take advantage of rolling review, where a company submits completed sections of its Biologic License Agreement for FDA review, as opposed to waiting for all BLA sections to be completed.
If successful, ADP101 could be eligible for Priority review, and could bring important new drugs to patients earlier and address unmet medical needs.
Ashley Dombkowski, chief executive officer and co-founder of Alladapt, said, “The FDA’s decision… signifies an important milestone for people suffering from the substantial burden of food allergy.
“We are excited to collaborate even more closely with the FDA as we move ahead to expedite [the] development of this important therapy.”
