Moonlight Therapeutics Launches First-in-Human Phase I Trial of MOON101 for Peanut Allergy
Moonlight Therapeutics, Inc., a clinical-stage biotechnology company focused on developing innovative treatments for food allergies, has announced the initiation of its first-in-human Phase I clinical trial evaluating MOON101, an investigational immunotherapy designed to treat peanut allergy. The study, known as SURVEYOR, marks a significant milestone for the company as it advances its proprietary intradermal immunotherapy platform from preclinical research into clinical development.
The launch of the trial represents an important step toward addressing one of the most common and potentially life-threatening food allergies worldwide. Peanut allergy affects millions of children and adults and remains a major public health challenge due to the risk of severe allergic reactions and the constant need for allergen avoidance. Through MOON101, Moonlight Therapeutics aims to develop a treatment that could help modify the immune system’s response to peanuts while offering a more convenient and patient-friendly administration method compared with existing approaches.
The Phase I study, formally titled Safety of MOON101 for the Treatment of Peanut Allergy, is registered on ClinicalTrials.gov under identifier NCT07580898. Researchers expect the study to enroll approximately 40 participants at multiple clinical research centers across the United States.
Advancing a Novel Approach to Peanut Allergy Treatment
Peanut allergy is among the most serious food allergies and is a leading cause of anaphylaxis, a severe allergic reaction that can become life-threatening if not treated promptly. Individuals living with peanut allergy often face significant lifestyle limitations, anxiety regarding accidental exposure, and the need to carry emergency medications such as epinephrine.
While recent advances in allergy treatments have expanded therapeutic options, there remains a substantial need for approaches that are safe, convenient, and suitable for long-term use across a broad patient population.
Moonlight Therapeutics is seeking to address these challenges through its proprietary intradermal immunotherapy platform. Unlike traditional allergy treatments that may involve oral exposure or injections, MOON101 utilizes a minimally invasive microneedle skin stamp designed to deliver precise microgram doses of peanut extract directly into the skin.
The treatment device is applied to the skin for only a few minutes before being removed. This delivery method is intended to leverage the skin’s immune environment to help train the immune system to tolerate peanut allergens while minimizing treatment burden for patients.
The company believes the platform could ultimately support at-home administration, potentially improving convenience and accessibility for individuals and families managing peanut allergy.
Transitioning From Preclinical Research to Human Studies
The initiation of SURVEYOR marks the first time MOON101 will be evaluated in human participants.
According to Moonlight Therapeutics, extensive preclinical research has provided encouraging evidence supporting the safety and potential effectiveness of the platform. These findings formed the basis for advancing the program into clinical testing and securing regulatory clearance to begin human studies.
Samir Patel, Ph.D., co-founder and Chief Executive Officer of Moonlight Therapeutics, described the study launch as a major achievement for both the company and the broader food allergy community.
Patel noted that the beginning of the SURVEYOR trial represents the transition of MOON101 from promising laboratory and preclinical work into clinical evaluation. He emphasized that the company’s long-term objective is to develop a therapy capable of safely modifying immune responses to peanuts and reducing the likelihood of severe allergic reactions among affected individuals.
The move into clinical development also reflects growing interest within the biotechnology sector in novel immunotherapy approaches that seek to address the underlying causes of allergic disease rather than simply managing symptoms.
Design of the SURVEYOR Trial
The Phase I SURVEYOR study has been designed primarily to evaluate the safety and tolerability of MOON101 in individuals with physician-confirmed peanut allergy.
The open-label, ascending-dose trial will enroll adults, adolescents, and children ranging in age from 4 to 55 years. Researchers will introduce participants in a stepwise manner, beginning with adult patients before expanding enrollment to adolescent and pediatric populations.
This sequential enrollment strategy is commonly used in early-stage clinical development to ensure careful safety monitoring as new therapies are evaluated in younger age groups.
Participants enrolled in the study will receive escalating doses of MOON101 over the course of five treatment visits. Throughout the trial, investigators will closely monitor treatment-emergent adverse events, assess tolerability, and evaluate immune system responses associated with the therapy.
The information generated from the study is expected to provide critical data regarding appropriate dose levels, treatment schedules, and overall safety characteristics that can guide future clinical development efforts.
Although the trial is not designed to establish efficacy, researchers will collect immunologic data that may offer early insights into how the treatment interacts with the immune system and whether it demonstrates signs of biological activity.
Collaboration With Experienced Clinical Research Partners
Moonlight Therapeutics is conducting the SURVEYOR study in collaboration with a network of leading academic food allergy centers and experienced clinical research organizations.
The company has partnered with Dr. Vince Clinical Research, a contract research organization with expertise in supporting early-stage clinical development programs.
Bradley Vince, DO, Chief Executive Officer and Chief Medical Officer of Dr. Vince Clinical Research, stated that the organization is pleased to support the evaluation of this novel microneedle-based treatment approach.
According to Vince, the study has been carefully designed to generate foundational clinical data regarding the safety, tolerability, and early clinical profile of MOON101. He noted that the findings will help inform dose-escalation strategies and support future development across adult, adolescent, and pediatric patient populations.
The involvement of experienced clinical development specialists is expected to help ensure high-quality study execution and comprehensive safety oversight throughout the trial.
Engaging Leading Food Allergy Research Centers
A key component of the SURVEYOR program is its collaboration with recognized academic institutions specializing in food allergy research.
By partnering with leading food allergy centers across the United States, Moonlight Therapeutics aims to leverage the expertise of investigators who have extensive experience studying allergic diseases and evaluating emerging therapies.
The multi-site strategy is designed to promote consistent study conduct, rigorous safety monitoring, and reliable data collection across participating centers.
Researchers believe that involving experienced food allergy specialists will be particularly valuable as the company evaluates this novel treatment platform in diverse patient populations.
The study’s leadership includes Brian P. Vickery, M.D., Professor of Pediatrics at Emory University, who serves as protocol chair for the trial.
Vickery emphasized the continuing need for improved treatment options for individuals living with peanut allergy. He noted that despite advances in the field, many patients still lack access to therapies that are both effective and convenient.
According to Vickery, the encouraging preclinical findings supporting MOON101 have generated interest among researchers, and the clinical trial will provide an important opportunity to evaluate the safety and tolerability of the investigational therapy in peanut-allergic individuals.
Support From Federal Research Programs
The initiation of the SURVEYOR trial follows review of Moonlight Therapeutics’ Investigational New Drug (IND) application by the U.S. Food and Drug Administration, enabling the company to proceed with human clinical testing.
The program has also benefited from substantial support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Moonlight Therapeutics previously received a multi-million-dollar Fast-Track Small Business Innovation Research (SBIR) clinical trial grant from NIAID to support the development and clinical evaluation of MOON101.
The grant reflects federal interest in advancing innovative technologies aimed at improving the management of food allergies and reducing the burden these conditions place on patients, families, and healthcare systems.
Government funding has played a significant role in helping emerging biotechnology companies translate promising scientific discoveries into clinical-stage programs, particularly in areas with substantial unmet medical need.
As the SURVEYOR study begins enrollment, Moonlight Therapeutics enters an important new phase in the development of its food allergy platform. The company hopes that the data generated from this first-in-human trial will establish the safety foundation necessary for larger studies evaluating the therapy’s ability to reduce allergic sensitivity and improve patient outcomes.
If successful, MOON101 could represent a new generation of allergen-specific immunotherapy that combines targeted immune modulation with a minimally invasive delivery system. The possibility of a convenient treatment that may eventually be administered at home could offer meaningful advantages for patients and caregivers seeking alternatives to current management strategies.
While significant clinical development work remains ahead, the initiation of the Phase I SURVEYOR trial marks a critical step toward advancing innovative treatment options for the millions of people affected by peanut allergy and underscores the growing momentum behind next-generation approaches to allergy immunotherapy.
About MOON101
MOON101 is an investigational intradermal allergen immunotherapy designed to treat peanut allergy using a proprietary microneedle delivery platform. The therapy utilizes a small dermal stamp containing coated microneedles that deliver peanut extract within minutes into the upper layers of the skin to target immune cells involved in allergic responses.
About Moonlight Therapeutics
Moonlight Therapeutics is a clinical stage biotechnology company based in Atlanta, Georgia, developing an allergen-specific immunotherapy platform for food allergies. The company’s proprietary intradermal delivery technology is designed to modulate immune responses through minimally invasive allergen administration and may be adaptable for multiple food allergies.
