Moonlight Therapeutics Launches First-in-Human Trial of Microneedle Peanut Allergy Treatment
核心洞察
Moonlight Therapeutics (搜索) has initiated SURVEYOR, a Phase I clinical trial evaluating MOON101 (搜索), an investigational microneedle-delivered immunotherapy for peanut allergy (搜索) treatment.
The first-in-human study will enroll approximately 40 participants aged 4-55 years across multiple U.S. sites to assess safety and tolerability of the intradermal therapy.
MOON101 (搜索) utilizes a minimally invasive skin stamp containing microneedles that deliver microgram doses of peanut extract, designed for potential at-home administration.
Moonlight Therapeutics (搜索) has launched SURVEYOR, a Phase I clinical trial marking the first human testing of MOON101 (搜索), an innovative microneedle-delivered immunotherapy for peanut allergy (搜索). The Atlanta-based biotechnology company announced the initiation of this first-in-human study, which represents a significant milestone in advancing novel treatment approaches for food allergies (搜索).
Novel Microneedle Delivery Platform
MOON101 (搜索) employs a proprietary intradermal delivery system featuring a minimally invasive microneedle skin stamp designed to introduce microgram doses of peanut extract within the skin. 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 (搜索) involved in allergic responses. The skin stamp is applied for a few minutes and then removed, offering a potentially convenient, low-burden treatment option suitable for at-home administration.
"This is an exciting milestone for Moonlight Therapeutics (搜索) and for the millions of families impacted by peanut allergy (搜索)," said Samir Patel, Ph.D., co-founder and Chief Executive Officer of Moonlight Therapeutics. "Initiating SURVEYOR marks the transition of MOON101 (搜索) 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."
Trial Design and Objectives
The SURVEYOR study (ClinicalTrials.gov Identifier: NCT07580898) is an open-label, ascending-dose Phase I trial designed to evaluate the safety and tolerability of MOON101 (搜索) in peanut-allergic adults, adolescents, and children. The study is expected to enroll approximately 40 participants across multiple clinical sites in the United States, sequentially enrolling individuals between the ages of 4 and 55 years with physician-confirmed peanut allergy (搜索).
The study's primary objective is to assess the safety of MOON101 (搜索). 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 (搜索) is pleased to collaborate with Moonlight Therapeutics (搜索) in the evaluation of the safety, tolerability and early clinical profile of this novel microneedle delivery system for peanut allergy (搜索) 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 (搜索) across adult, adolescent and pediatric populations."
Addressing Unmet Medical Need
The trial 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 (搜索)," 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 (搜索) in peanut-allergic individuals."
Regulatory Support and Funding
The trial follows FDA review of Moonlight Therapeutics (搜索)' Investigational New Drug (IND) application for MOON101 (搜索) 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.
Moonlight Therapeutics (搜索)' proprietary intradermal delivery technology is designed to modulate immune responses through minimally invasive allergen administration and may be adaptable for multiple food allergies (搜索), positioning the company to potentially address broader food allergy treatment needs beyond peanut allergy (搜索).