Moonlight Therapeutics has begun the SURVEYOR Phase I clinical trial to assess MOON101, an investigational immunotherapy for peanut allergy.

The ascending-dose, open-label trial represents the transition of MOON101 into clinical-stage development and will evaluate its tolerability and safety in adults, adolescents, and children with an allergy to peanuts.

The study marks the first-in-human trial of MOON101and plans to enrol up to 40 participants at various clinical sites across the US.

The trial enrols participants aged four to 55 years with a physician-confirmed peanut allergy.

MOON101 is an allergen-specific immunotherapy delivered using a minimally invasive microneedle skin stamp. Each application delivers microgram doses of peanut extract into the skin within minutes.

The treatment is designed for both convenience and low burden, potentially enabling at-home administration for patients.

Moonlight Therapeutics co-founder and CEO Samir Patel said: “This is an exciting milestone for Moonlight Therapeutics and for the millions of families impacted by peanut allergy.

“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 study will first enrol adults, followed by adolescents and children, with escalating doses of MOON101 administered over five visits.

The trial will examine treatment-emergent adverse events, overall tolerability, and immune responses to the therapy.

Moonlight Therapeutics is conducting the study in collaboration with leading academic food allergy centres in the US. This partnership aims to ensure robust safety oversight, uniform trial conduct, and high-quality early-phase data.

The trial follows the FDA's review of Moonlight Therapeutics’ investigational new drug application and expands on earlier support from the National Institute of Allergy and Infectious Diseases, which granted funding for the SURVEYOR study.