Moonlight Therapeutics, Inc., a clinical stage biotechnology company developing a proprietary intradermal immunotherapy platform for food allergies, today announced the initiation of SURVEYOR, a Phase I clinical trial, evaluating MOON101 for the treatment of peanut allergy, marking the program’s transition into clinical-stage development.
SURVEYOR, a first-in-human clinical study, titled Safety of MOON101 for the Treatment of Peanut Allergy (ClinicalTrials.gov Identifier: NCT07580898), is designed to evaluate the safety and tolerability of MOON101 in peanut-allergic adults, adolescents, and children. The study is expected to enroll approximately 40 participants across multiple clinical sites in the United States.
MOON101 is Moonlight Therapeutics’ investigational allergen-specific immunotherapy delivered through a minimally invasive microneedle skin stamp designed to introduce microgram doses of peanut extract within the skin. The skin stamp is applied for a few minutes and then removed. The platform is intended to provide a convenient, low-burden treatment option that is suitable for at-home administration.
“This is an exciting milestone for Moonlight Therapeutics and for the millions of families impacted by peanut allergy,” said Samir Patel, Ph.D., 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.”
The open-label, ascending-dose Phase I trial will sequentially enroll adults, adolescents, and children between the ages of 4 and 55 years with a physician-confirmed peanut allergy. The study’s primary objective is to assess the safety of MOON101. Participants will receive escalating doses of MOON101 over five treatment visits, with investigators evaluating treatment-emergent adverse events, tolerability, and immunologic responses.
“As the CRO supporting the SURVEYOR study, Dr. Vince Clinical Research is pleased to collaborate with Moonlight Therapeutics in the evaluation of the safety, tolerability and early clinical profile of this novel microneedle delivery system for peanut allergy treatment,” said Bradley Vince, DO, CEO and Chief Medical Officer of Dr. Vince Clinical Research. “The study is designed to generate key early phase data to inform dose escalation strategy and support the continued clinical development of MOON101 across adult, adolescent and pediatric populations.”
The study is being conducted in collaboration with leading academic food allergy centers across the United States, bringing together experienced investigators and institutions recognized for advancing food allergy research. This site strategy is intended to support comprehensive safety oversight, consistent study execution, and the generation of high-quality early phase data across participating sites.
“There remains a significant unmet need for safe, convenient, and accessible treatment options for peanut allergy,” said Brian P. Vickery, M.D., 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 trial follows FDA review of Moonlight Therapeutics’ Investigational New Drug (IND) application for MOON101 and builds upon prior support from the National Institute of Allergy and Infectious Diseases (NIAID), which awarded Moonlight a multi-million-dollar Fast-Track Small Business Innovation Research clinical trial grant (U44AI165328) to support SURVEYOR. Additional study information is available on Moonlight Therapeutics’ website and ClinicalTrials.gov (NCT07580898).
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.
Forward-Looking Statements
This press release contains forward-looking statements regarding Moonlight Therapeutics’ clinical development plans, regulatory activities, anticipated clinical progress, and the potential therapeutic benefits of MOON101. Actual results may differ materially due to risks and uncertainties inherent in biotechnology research and drug development, including clinical trial outcomes, regulatory decisions, funding availability, and other factors. Moonlight Therapeutics undertakes no obligation to update forward-looking statements except as required by law.
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