Childrens Leads First-in-Human Peanut Allergy Trial Testing Atlanta-Based Microneedle Skin Stamp

Atlanta, GA (June 24, 2026) – Children’s Healthcare of Atlanta today opens a first-in-human Phase 1 clinical trial to study the safety and tolerability of a microneedle stamp applied to the skin, with the eventual goal of determining whether it might prevent peanut allergy reactions through desensitization in future studies. The stamp was developed by Moonlight Therapeutics, Inc., an Atlanta-based biotech company, and received clearance from the U.S. Food and Drug Administration (FDA) to be tested in humans for the first time in late 2025.

“The microneedle stamp is a stainless steel device the size of a nickel which is coated with small doses of peanut protein and designed to be applied to the skin of the forearm for about three minutes before removal,” said Brian Vickery, MD, Chief of Allergy and Immunology at Children’s Healthcare of Atlanta and Principal Investigator of the multi-site trial. “Since the microneedles only go slightly into the skin, the application may be less painful than an injection, and rather than the peanut proteins sitting on the outside like other skin patch therapies, we believe the stamp may be more effective at improving immune response to peanut allergy.”

Peanut allergy is one of the most common food allergies, affecting more than 1.2 million children in the U.S. Estimates suggest that approximately 30,000 children in metro Atlanta are affected by a peanut allergy. Six million children, about one in 13 in the U.S., have at least one food allergy. This translates into at least one child in every classroom. Only two therapies have been FDA-approved for food allergies. One requires a subcutaneous injection of an antibody every two to four weeks and the other, which was recently discontinued by the manufacturer, involves mixing powder into food daily.

“The microneedle approach may be a way to safely and precisely deliver, in just three minutes, a controlled dose of peanut protein to the immune system that could facilitate the next generation in advanced immunotherapy,” said Dr. Vickery, who is also the Vice-Chair of Clinical Research in the Department of Pediatrics at Emory University School of Medicine.

In this study, researchers will start with one microgram of peanut protein and gradually increase the dose as tolerated, to determine which dose could be tested in subsequent studies to create a change in immune response. Initially the microneedle stamp will be applied under supervision in the research clinic once per week. Participants will receive an active stamp on one forearm and a placebo on the other forearm each time the stamp is administered. The overall goal of the microneedle program is to test if repeated exposures through this therapy can alter the immune response to peanuts and create clinical desensitization. Patients living with peanut allergy are at risk of anaphylactic reaction, which can be serious if untreated and can occur from very small amounts of exposure to peanuts. Often, rescue medications like epinephrine are needed during a reaction.

“We know how busy the lives of food-allergic families are, so we designed the microneedle stamp with convenience in mind,” said Samir Patel, PhD, President and CEO of Moonlight Therapeutics, Inc. “The technology behind it allows for a minimally invasive way to administer the allergen within the skin in a matter of minutes. It requires no eating or ingestion of peanuts and is designed for home use.”

The trial, led by Children’s and Emory, will recruit young adults and adults aged 18-26 to be seen at Children’s and adults aged 27-55 at Emory in the initial cohort. Following a safety review, if the stamp is determined to be safe in adults, younger teens will be enrolled into the second cohort. Children as young as four years of age could be enrolled in the third cohort, following an adolescent safety review. Four other sites including the University of North Carolina (UNC) at Chapel Hill, the University of Arkansas, the University of Michigan, and a clinical research organization in Nebraska will participate. The trial is funded by a National Institutes of Health (NIH) U44 Small Business Innovation Research (SBIR) grant to Moonlight Therapeutics, Inc. and subcontracted to Emory University and Children’s for this project. Dr. Vickery has ownership interest in Moonlight Therapeutics, Inc.

Microneedles are currently most used as vaccination approaches in humans to improve accessibility globally. Mark Prausnitz, PhD, Professor, Georgia Tech, is a key academic developer of microneedle technology for a variety of applications, and the founders of Moonlight Therapeutics, Inc., Dr. Patel and Harvinder Gill, PhD, Scientific Founder, were formerly post-doctoral students in his lab.

For more information:

Julie Kuchta
404-785-3823
julie.kuchta@choa.org

Lucy Bertsch
404-785-4430
lucy.bertsch@choa.org