Alladapt Immunotherapeutics gains FDA Fast Track Designation for ADP101 as food allergy treatment
Betsy Goodfellow | November 24, 2023 | News story | Research and Development | Alladapt Immunotherapeutics, Allergic Disorders, FDA, fast track designation, food allergy
Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food and Drug Administration (FDA) as a treatment for one or more food allergens.
ADP101 is currently the most advanced multi-food oral immunotherapy (mOIT) candidate in development, and there are currently no FDA-approved OIT treatments for multi-food allergy to foods other than peanuts.
This Fast Track Designation allows for the expedited development of ADP101 as a treatment for food allergy, including the simultaneous treatment of multiple food allergies and the treatment of single food allergies, in paediatric patients between the ages of four and 17 years with confirmed allergies to one or more of the following allergens: almond, cashew, chicken egg, codfish, cow milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut and wheat.
Ashley Dombkowski PhD, chief executive officer and co-founder of Alladapt, commented: “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.”
Betsy Goodfellow
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