A phase 1 study is testing the safety of a microneedle device designed to deliver peanut protein through the skin for desensitization.
RT’s Three Key Takeaways:
- Microneedle Technology: The nickel-sized stainless steel device delivers peanut protein directly into the skin during a three-minute application to trigger an immune response.
- Clinical Trial Progression: The phase 1 study will first evaluate safety in adults before expanding to include adolescents and children as young as 4 years old.
- Treatment Convenience: The stamp is designed for potential home use and requires no ingestion of peanut products, offering a minimally invasive alternative to injections or oral therapies.
Children’s Healthcare of Atlanta has initiated a first-in-human phase 1 clinical trial to evaluate a microneedle skin stamp for peanut allergy treatment, according to the organization. The study focuses on the safety and tolerability of the device, which aims to desensitize patients to peanut proteins through controlled exposure.
The stamp, developed by Moonlight Therapeutics Inc, received clearance from the FDA for human testing in late 2025. The stainless steel device is the size of a nickel and is coated with small doses of peanut protein. It is designed to be applied to the skin of the forearm for approximately three minutes before removal.
“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,” said Brian Vickery, MD, chief of allergy and immunology at Children’s Healthcare of Atlanta and principal investigator of the multi-site trial, in a news release.
Peanut allergy is a common condition affecting more than 1.2 million children in the US, the release stated. Currently, only two therapies have received FDA approval for food allergies, including a subcutaneous injection and an oral powder that was recently discontinued by its manufacturer.
The trial will initially recruit adults aged 18 to 55. Following a safety review, the study will expand to include younger teens, and a third cohort may include children as young as 4 years old. Researchers plan to start with one microgram of peanut protein and gradually increase the dose to determine the optimal level for future immune response studies.
“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 Vickery, who is also the vice-chair of clinical research in the department of pediatrics at Emory University School of Medicine, in a news release.
The project is funded by a National Institutes of Health (NIH) grant. Participants in the study receive an active stamp on one forearm and a placebo on the other once per week under clinical supervision. The trial is being conducted at multiple sites, including Emory University, the University of North Carolina at Chapel Hill, the University of Arkansas, the University of Michigan, and a clinical research organization in Nebraska.
“The technology behind it allows for a minimally invasive way to administer the allergen within the skin in a matter of minutes,” said Samir Patel, PhD, president and CEO of Moonlight Therapeutics, Inc., in a news release. “It requires no eating or ingestion of peanuts and is designed for home use.”
