FDA grants fast track designation to multi-food oral immunotherapy
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Key takeaways:
- ADP101 includes 15 foods from the nine most common allergen groups.
- Responses were dose-dependent and clinically meaningful with favorable safety and tolerability.
The FDA has granted fast track designation to ADP101, an oral immunotherapy designed to simultaneously treat one or more of the most common food allergies, Alladapt Immunotherapeutics announced in a press release.
ADP101 is a dry powder mixture that includes almond, cashew, chicken egg, codfish, cow milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut and wheat, hailing from the nine most common allergen groups.
“The FDA’s decision to grant ADP101 fast track designation signifies an important milestone for people suffering from the substantial burden of food allergy,” Ashley Dombkowski, PhD, CEO and cofounder of Alladapt, said in the press release.
There are no current FDA-approved oral immunotherapy treatments for multi-food allergies or for foods other than peanut, according to the press release.
In the company’s phase 1/2 Harmony trial, ADP101 generated dose-dependent, clinically meaningful responses as a multi-food desensitization therapy with a favorable safety and tolerability profile in patients aged 4 to 17 years with confirmed allergies to one or more of the food sources used in the product.
Response rates included 55% for patients on high doses of ADP101, 38.1% for patients on low doses of ADP101 and 20% for the placebo group. Also, 55.6% of the high-dose group tolerated at least 600 mg of two or more of the qualifying foods.
The ongoing Encore open-label extension of the Harmony study will assess the long-term use of ADP101 by these patients.
In an independent study, Alladapt Immunotherapeutics reported, 93% of patients who sought ED treatment for food allergy reactions were allergic to multiple foods or to foods other than peanut.
“Our team is thrilled to be at the forefront of developing a new treatment that addresses such a huge unmet need,” Dombkowski said.
Designed to expedite the development of new drugs for serious or life-threatening conditions, fast track allows more frequent meetings and written communications between companies and the FDA to discuss developmental plans, clinical trial designs and data collection.
Drugs with a fast track designation also are eligible for rolling review, where companies can submit sections of their biologic license applications as they are completed instead of waiting to submit the full document, and priority review, which brings new drugs to patients earlier to address unmet medical needs.
“We are excited to collaborate even more closely with the FDA as we move ahead to expedite development of this important therapy,” Dombkowski said.