Children’s Healthcare of Atlanta has opened a first-in-human clinical trial testing whether a microneedle skin stamp the size of a nickel could change how peanut allergies are treated in the United States. The Phase 1 trial, designated SURVEYOR, is evaluating the safety and tolerability of MOON101, an investigational therapy developed by Atlanta-based biotech company Moonlight Therapeutics, Inc. The stainless steel stamp is coated with small doses of peanut protein and designed to be pressed against the forearm for approximately three minutes, delivering the allergen into the upper layers of the skin without any ingestion. Dr. Brian Vickery, Chief of Allergy and Immunology at Children’s Healthcare of Atlanta and Professor of Pediatrics at Emory University, is serving as principal investigator on the multi-site study.
Key Takeaways
- Children’s Healthcare of Atlanta is leading the SURVEYOR trial, a first-in-human Phase 1 study evaluating the safety of a microneedle skin stamp (MOON101) for peanut allergy treatment.
- The stamp was developed by Moonlight Therapeutics, an Atlanta-based biotech founded by Georgia Tech postdoctoral researchers, and received FDA clearance for human testing in late 2025.
- The device is applied to the forearm for three minutes, requires no ingestion, and is designed for home use — a departure from existing therapies that require oral exposure to peanut protein.
- The trial will enroll 40 participants across multiple U.S. academic food allergy centers, beginning with adults and progressing to adolescents and then children ages 4 to 11.
- Peanut allergy affects more than 1.2 million children in the United States, with only two FDA-approved treatments currently available, one of which was recently discontinued.
How Does The Microneedle Stamp Work?
The science behind MOON101 targets the immune system through the skin rather than the gut, a fundamental departure from the oral immunotherapy approach that has dominated food allergy treatment. The stamp contains an array of tiny coated microneedles that penetrate just deep enough into the skin to reach Langerhans cells and dermal dendritic cells — specialized immune cells that play a central role in how the body recognizes and responds to allergens.
The concept is that by delivering controlled, microgram-level doses of peanut protein directly to these immune cells over time, the therapy could train the immune system to tolerate peanut exposure rather than mount the potentially life-threatening allergic response that currently defines the condition. The delivery method bypasses the gastrointestinal tract entirely, which is where most adverse reactions to existing oral immunotherapy occur.
Moonlight Therapeutics CEO and co-founder Samir Patel described the technology in practical terms. “The technology behind it allows for a minimally invasive way to administer the allergen within the skin in a matter of minutes,” Patel stated in the company’s press release. “It requires no eating or ingestion of peanuts and is designed for home use.”
The home-use design is significant for clinical adoption. Current FDA-approved peanut allergy therapies require patients to consume peanut protein orally, a process that carries risk of allergic reactions and demands medical supervision during dose escalation. A stamp that can be self-administered at home in three minutes, without any oral exposure, would represent a fundamentally different patient experience and could meaningfully expand the number of families willing to pursue treatment.
What Is The Atlanta Connection?
The trial’s roots run through three of Atlanta’s defining institutions: Children’s Healthcare of Atlanta, Emory University, and Georgia Institute of Technology.
Moonlight Therapeutics is headquartered in Atlanta, and the company’s founding story traces directly to Georgia Tech’s bioengineering ecosystem. Co-founders Samir Patel and Harvinder Gill both completed postdoctoral work in the laboratory of Mark Prausnitz, a Georgia Tech professor who is widely recognized as one of the pioneering developers of microneedle technology. Prausnitz’s lab has spent years advancing microneedle platforms for vaccine delivery and other medical applications, and the Moonlight team adapted that foundational research specifically for food allergy immunotherapy.
Dr. Brian Vickery’s role as principal investigator connects the trial to both Children’s Healthcare and Emory’s Department of Pediatrics, where Vickery directs the Food Allergy Center. Vickery has been involved in food allergy clinical trials across multiple stages of development, including registration trials that led to FDA approvals. His participation signals the institutional credibility that a first-in-human trial requires to attract enrollment and generate data that regulators will take seriously.
The convergence of a Georgia Tech-born technology, an Atlanta-based biotech company, and a Children’s Healthcare-led clinical program illustrates the kind of research-to-commercialization pipeline that Atlanta’s life sciences sector has been building toward for years. The city of Brookhaven, located in DeKalb County, was recently designated a BioReady Gold Community by Georgia Life Sciences, reflecting the broader regional investment in positioning Metro Atlanta as a competitive destination for biotech development and clinical research.
What Does The Trial Look Like?
The SURVEYOR trial is designed to evaluate safety and tolerability first, not efficacy. The study will enroll 40 participants in a staged sequence: peanut-allergic adults will be enrolled first, followed by adolescents, and then children ages 4 to 11. The staged approach allows researchers to establish safety data in adults before exposing younger and more vulnerable populations to the investigational therapy.
Participants will receive the MOON101 stamp on one arm for three minutes during each treatment session. The trial is being conducted across multiple academic food allergy centers in the United States, including sites at Children’s Healthcare of Atlanta, Arkansas Children’s Research Institute, the University of Michigan, the University of North Carolina at Chapel Hill, and Dr. Vince Clinical Research in Overland Park, Kansas.
The multi-site structure is intended to support comprehensive safety oversight, consistent study execution, and the generation of data across participating institutions with established food allergy research programs. Moonlight Therapeutics received FDA clearance for human testing in late 2025, and the trial’s formal initiation was announced in June 2026.
Why Does This Matter For The 1.2 Million Children With Peanut Allergies?
The treatment landscape for peanut allergy in the United States is remarkably thin given the condition’s prevalence. More than 1.2 million children live with peanut allergy, and the condition is the leading cause of food-related anaphylaxis. Until recently, two FDA-approved therapies existed: a subcutaneous injection and an oral powder. The oral powder was recently discontinued by its manufacturer, narrowing the available options further and leaving families with fewer clinical tools to manage a condition that carries daily risk.
Existing oral immunotherapy requires patients to consume increasing doses of peanut protein over months, a process that frequently triggers gastrointestinal side effects and allergic reactions. Many families discontinue treatment because of side effects or the logistical burden of supervised dosing visits. A therapy that eliminates oral exposure entirely and can be administered at home in minutes would address the two primary barriers — safety and convenience — that have limited uptake of current treatments.
The SURVEYOR trial is a Phase 1 study, meaning it is designed to assess whether the stamp is safe, not whether it works as a therapeutic. If the safety data supports continued development, Moonlight Therapeutics would need to conduct Phase 2 and Phase 3 trials to demonstrate efficacy before seeking FDA approval. That timeline typically spans several years.
For now, the significance of the trial lies in the proof of concept: that a technology developed in a Georgia Tech laboratory, commercialized by an Atlanta startup, and tested at one of the nation’s leading pediatric research hospitals is moving through the regulatory process toward a potential therapy that could change the daily reality for more than a million American children and their families.
FAQs
What is the MOON101 microneedle stamp? MOON101 is an investigational therapy developed by Atlanta-based Moonlight Therapeutics. The device is a stainless steel stamp the size of a nickel, coated with small doses of peanut protein. It is applied to the forearm for approximately three minutes, delivering the allergen into the upper layers of the skin to target immune cells involved in allergic responses.
Who is leading the clinical trial? Dr. Brian Vickery, Chief of Allergy and Immunology at Children’s Healthcare of Atlanta and Professor of Pediatrics at Emory University, is the principal investigator. The trial is being conducted across multiple academic food allergy centers in the United States.
How many people will participate in the SURVEYOR trial? The Phase 1 trial will enroll 40 participants in a staged sequence: adults first, then adolescents, then children ages 4 to 11. The staged design allows researchers to establish safety data in older participants before enrolling younger populations.
Does the stamp require patients to eat peanuts? No. The stamp delivers peanut protein through the skin, bypassing the gastrointestinal tract entirely. This is a fundamental departure from existing oral immunotherapy, which requires patients to consume peanut protein and carries a risk of gastrointestinal side effects and allergic reactions.
How is Moonlight Therapeutics connected to Georgia Tech? Moonlight Therapeutics co-founders Samir Patel and Harvinder Gill completed postdoctoral work in the laboratory of Georgia Tech Professor Mark Prausnitz, a leading developer of microneedle technology. The company adapted Prausnitz’s foundational research for food allergy immunotherapy.
When could this treatment become available? The SURVEYOR trial is a Phase 1 safety study. If results support further development, Moonlight Therapeutics would need to conduct Phase 2 and Phase 3 efficacy trials before seeking FDA approval, a process that typically spans several years.
