Peanut allergy affects more than 1.2 million children in the US and has only 2 FDA-approved therapies: an injectable antibody administered every 2 to 4 weeks without altering the underlying immune response to the allergen (omalizumab) and an oral immunotherapy powder recently discontinued by its manufacturer (Palforzia).¹ A first-in-human phase 1 trial testing a new option, a microneedle skin stamp, opened June 24, 2026, at Children's Healthcare of Atlanta.¹ The device, developed by Atlanta-based Moonlight Therapeutics, Inc., received FDA clearance for human testing in late 2025.¹

The stamp delivers peanut protein < 1 mm into the outer layers of skin during a 3-minute application, unlike epicutaneous patches, where protein sits on the skin surface for continuous wear.² Investigators are using an ascending-dose design, starting participants at 1 microgram of peanut protein and escalating weekly to a ceiling of 100 micrograms if tolerated.¹ The study spans 5 US sites led by Children's and Emory University, enrolling adults first before moving to adolescent and pediatric cohorts pending safety review.¹

HCPLive spoke with lead investigator Brian Vickery, MD, chief of allergy and immunology at Children's Healthcare of Atlanta and vice chair of clinical research in the department of pediatrics at Emory University School of Medicine, about this ongoing trial. In this Q&A, he discusses the mechanistic rationale behind the microneedle platform, the trial's dose-escalation design and safety monitoring, and his outlook for where this approach could fit into the food allergy treatment landscape.

Q&A: Inside the First-in-Human Peanut Allergy Microneedle Stamp Trial

HCPLive: How does the microneedle delivery mechanism differ mechanistically from existing epicutaneous patch therapies, and why might it improve immune response?

Vickery: With epicutaneous immunotherapy, which is also in development, the peanut proteins sit on the outside of the skin. They're attached to a disc adhered to the skin and designed to be worn continuously, 24/7. With continued use, the peanut proteins release from the patch and sit on the outside of the skin, where they may come in contact with immune cells but remain on the other side of the skin barrier.

With microneedles, the delivery system actually inserts the peanut proteins through the outer layers of skin, less than a millimeter deep. It's still very superficial, but it breaks through the top layer of skin, which may make it easier for the immune cells residing within the skin to interact with those peanut proteins, which we hope will improve its effectiveness. Importantly for patients, it also does not require them to use the system 24/7. It's applied for just a few minutes and then removed.

HCPLive: Can you walk through the dose-escalation design, starting at 1 microgram of peanut protein?

Vickery: Like many other phase 1 studies, participants are exposed to a range of doses starting with a tiny first dose, 1 microgram of peanut protein. For reference, a microgram is 1/1000th of a milligram, and a peanut kernel is about 300 milligrams, so we're talking about a tiny fraction of 1 peanut on the first day. Participants come into the research unit, have 1 microgram placed, and that's the only exposure for the first day. We observe them, discharge them home, and they come back a week later to try a slightly higher dose, 5 micrograms, then 10 micrograms the next week, and so on, and we cap the exposure at 100 micrograms if tolerated.

HCPLive: What safety signals or adverse events are you watching most closely in this first-in-human application?

Vickery: The allergic reactions we're most concerned about would be a systemic allergic reaction, where patients may experience symptoms in different parts of their body, potentially even anaphylaxis. We're on guard for that and prepared to manage it if it happens. More likely, what we'll see is localized allergic reactions around the injection site. When you expose sensitive people to the thing they're allergic to, you often get itching, redness, swelling, [and] hives.

HCPLive: What did earlier immunotherapy approaches teach you about dosing precision that shaped this trial's design?

Vickery: We can establish the average dose at which people might react, but we recognize from previous studies there's quite a range of sensitivity. Some patients are exquisitely sensitive to tiny amounts, which is why this microneedle platform is so attractive: the dose can be very precisely controlled and reliably administered even at these tiny microgram quantities.

HCPLive: If early safety and tolerability data are positive, what would the path toward a pivotal efficacy trial look like?

Vickery: The next study would be a phase 2 study with repeated-dose administration over a period of months, perhaps up to 52 weeks. In food allergy, efficacy studies also include oral food challenges, both at baseline and at the end of treatment, to show how well or not the immunotherapy works to change reactivity. This current phase 1 study does not include food challenges, so that will be an important component of studies moving forward.

HCPLive: Is there anything else you'd like to highlight about the study and where it stands?

Vickery: It's important to know this is a phase 1 study, happening at 5 sites across the US, initially enrolling an adult cohort. Once the adult cohort closes, the data will be reviewed by a data safety and monitoring committee, and we will then ask that committee for permission to open the next cohort, which will be adolescents, and we'll repeat the process. We'll enroll 10 adolescents and then review those data with the data safety and monitoring committee, and if approved to do so, we would open a pediatric cohort down to age 4 and enroll 20 children.

Watch our video interview with Vickery here: Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy and Microneedle Peanut Allergy Trial Charts Path to Pivotal Testing.

References

1. Children's Healthcare of Atlanta. Children's leads first-in-human peanut allergy trial testing Atlanta-based microneedle skin stamp. Published June 24, 2026. Accessed August 18, 2026. https://www.choa.org/about-us/newsroom/childrens-leads-first-in-human-peanut-allergy-trial-testing-atlanta-based-microneedle-skin-stamp

2. Vickery B. Microneedle Stamp Enters Phase 1 Trial for Peanut Allergy Immunotherapy. HCPLive Published August 18, 2026. Accessed August 19, 2026. https://www.hcplive.com/view/microneedle-stamp-trial-peanut-allergy-immunotherapy

3. Vickery B. Microneedle Peanut Allergy Trial Charts Path to Pivotal Testing. HCPLive. Published August 19, 2026. Accessed August 19, 2026. https://www.hcplive.com/view/microneedle-peanut-allergy-trial-path-pivotal-testing