FDA Issues Fast Track Designation to ADP101 for Mono-, Multi-Food Allergies

Alladapt Immunotherapeutics, Inc., has received FDA Fast Track Designation for ADP101, its investigational multi-food oral immunotherapy designed to treat allergy to 1 or more significant food allergens. According to a press release from the company, ADP101 is the most advanced multi-food oral immunotherapy pharmaceutical candidate in development.¹

The Fast Track Designation provides FDA endorsement for expedited development of ADP101 as a treatment for food allergy in children ages 4 to 17 years with confirmed allergy to 1 or more of the following 15 foods contained in the drug product: almond, cashew, chicken egg, codfish, cow milk, hazelnut, peanut, pecan, pistachio, salmon, sesame seed, shrimp, soy, walnut, and wheat.¹

There are currently no FDA-approved oral immunotherapies for multi-food allergy or for allergy to foods other than peanut. An independent study of patients who sought emergency department treatment for allergic reactions to food over a 12-month period, 93% were either multi-allergic or allergic to foods other than peanut, and just 6.6% were allergic to peanut alone. This highlights the need for interventions to target multiple allergens.¹

“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,” said Ashley Dombkowski, PhD, CEO and co-founder of Alladapt, in the press release.¹

The designation was supported by data from Alladapt’s phase 1/2 Harmony trial (NCT04856865), evaluating the safety and efficacy of ADP101 for inducing desensitization in patients with single or multiple food allergies. Results presented at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Congress and the 2023 American College of Allergy, Asthma, and Immunology Annual Meeting demonstrated that the immunotherapy generated dose-dependent, clinically meaningful responses as a multi-oral immunotherapy food allergy desensitization therapy. It also had a favorable safety and tolerability profile in pediatric patients allergic to 1 or more of the food sources in the product.¹

In the Harmony study’s pediatric data, desensitization to 600 mg or more of protein from 1 or more qualifying allergens at 40 weeks was observed in 20%, 38.1%, and 55% in those receiving placebo, low-dose ADP101, and high-dose ADP101, respectively. Additionally, desensitization of 2 or more foods at the 600 mg of protein or higher threshold was seen in 0%, 22.2%, and 55.6% of the same dose groups, and desensitization to 2 or more foods at the 1000 mg or higher threshold was observed in 0%, 11.1%, and 44.4% of the same groups.²

Most treatment-emergent adverse events were classified as mild or moderate and occurred during the up-dosing treatment period. In the dose-maintenance phase, no adverse events were reported with a frequency of >15% in any treatment group, and there were no severe anaphylactic events or discontinuations for anaphylaxis attributed to ADP101. There was no evidence of treatment-associated sensitization to new allergens during the study.²

“Based on these Harmony data, we are now looking ahead to a phase 3 program to support regulatory approval of ADP101,” said Dana McClintock, MD, Alladapt’s chief medical officer, in a press release prior to the 2023 EAACI Congress. “Food allergy is a largely invisible, chronic disease that places a severe immunological and psychological burden on patients and their families. With limited treatment options, clinicians are actively seeking effective, practical interventions that could be broadly accessed by as many of their patients as possible. As we progress our clinical program, we intend to continue partnering with the food allergy community to ensure these needs are well reflected in our program.”²

The Fast Track program is designed to expedite the development of new drugs for the treatment of serious or life-threatening conditions. It allows more frequent meetings and written communications with FDA officials to discuss the drug’s development plan, clinical trial design, and data collection. Fast Track-designated drugs can also take advantage of rolling review, wherein a company can submit completed sections of its Biologics License Application for review by the FDA, rather than waiting until every section is complete.¹

References

1. Alladapt Immunotherapeutics Receives FDA Fast Track Designation for ADP101 for the Treatment of Mono- and Multi-Food Allergies. GlobeNewswire. November 22, 2023. Accessed November 22, 2023. https://www.globenewswire.com/en/news-release/2023/11/22/2784744/0/en/Alladapt-Immunotherapeutics-Receives-FDA-Fast-Track-Designation-for-ADP101-for-the-Treatment-of-Mono-and-Multi-Food-Allergies.html

2. Alladapt Immunotherapeutics Announces Topline Pediatric Data from Phase 1/2 Harmony Study Evaluting ADP101 for the Treatment of Patients with Mono- and Multi-Food Allergy, as Presented at the European Academy of Allergy and Clinical Immunology Hybrid Congress. News release. June 13, 2023. Accessed November 22, 2023. https://assets-global.website-files.com/5e4aeee404e0b868e6d9f7f0/6487b687b908c9bf3498a537_Alladapt%20%E2%80%93%C2%A0EAACI%20%E2%80%93%2013-JUN-2023.pdf