Moonlight Therapeutics, a clinical-stage biotechnology company developing a proprietary intradermal immunotherapy platform for food allergies, has initiated a Phase I clinical trial to evaluate MOON101 for the treatment of peanut allergy. The first-in-human study marks the program’s transition from promising preclinical research to clinical-stage development.
The SURVEYOR study is an open-label, dose-escalation clinical trial designed to evaluate the safety and tolerability of MOON101 in individuals with peanut allergy and to generate early clinical data to support future development. The trial is expected to enroll approximately 40 participants at multiple clinical sites in the United States. Eligible subjects include children, adolescents, and adults ages 4 to 55 with a physician-confirmed peanut allergy.
MOON101 is an investigational allergen-specific immunotherapy delivered via a minimally invasive microneedle skin stamp that introduces microgram doses of peanut extract into the upper layers of the skin. The therapy is intended to target immune cells involved in allergic responses while avoiding the burden of more invasive treatment approaches. The skin stamp is applied for only a few minutes before being removed and is intended to provide a convenient, at-home treatment option.
“This is an exciting milestone for Moonlight Therapeutics and for the millions of families impacted by peanut allergy,” said Samir Patel, PhD, co-founder and Chief Executive Officer of Moonlight Therapeutics. “Initiating SURVEYOR marks the transition of MOON101 from promising preclinical research into human studies. Our goal is to develop a patient-friendly therapy capable of safely modulating the immune response to peanuts and ultimately reducing the risk of severe allergic reactions.”
Participants in the study will receive escalating doses of MOON101 over five treatment visits. Investigators will monitor treatment-emergent adverse events, assess tolerability, and evaluate immunologic responses to better understand how the therapy interacts with the immune system. The resulting data will help inform future dose-escalation strategies and support continued development of MOON101 across pediatric, adolescent, and adult populations.
To support execution of the trial, Moonlight has partnered with Dr Vince Clinical Research, which is serving as the contract research organization for SURVEYOR. Dr Bradley Vince, DO, CEO and Chief Medical Officer of the organization, said the study is designed to generate critical early-phase data that will guide the program’s future clinical development.
The multicenter study is also being conducted in collaboration with leading academic food allergy centers across the United States. According to Moonlight, the site strategy is intended to provide comprehensive safety oversight, ensure consistent study execution, and generate high-quality early-phase data across participating institutions.
“There remains a significant unmet need for safe, convenient, and accessible treatment options for peanut allergy,” said Brian P Vickery, MD, Professor of Pediatrics at Emory University and protocol chair for the study. “We are encouraged by the preclinical data supporting this platform and look forward to evaluating the safety and tolerability of MOON101 in peanut-allergic individuals.”
The initiation of SURVEYOR follows the Food and Drug Administration’s review of Moonlight Therapeutics’ Investigational New Drug application for MOON101. The clinical program also builds upon prior support from the National Institute of Allergy and Infectious Diseases, which awarded the company a multi-million-dollar Fast-Track Small Business Innovation Research clinical trial grant to support the SURVEYOR study.
To learn more about the clinical trial and to apply, visit the SURVEYOR page at ClinicalTrials.gov.
