# Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies

> **NIH NIH R42** · MOONLIGHT THERAPEUTICS, INC. · 2020 · $55,000

## Abstract

Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies
Food allergies affect 15 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13,
in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there are no
approved therapies for food allergies anywhere in the world. Food allergies are expected to grow 10% annually
until 2022. It is also common for someone to have more than one allergy. This is a growing, underserved
global market that has few treatment options. A meaningful initial therapy would be one that reduces the
chance for anaphylactic reaction after accidental exposure. Based on surveys, allergists and patients believe a
therapy that reduces the chance for anaphylactic reaction from accidental exposure is meaningful and
worthwhile. Such a therapy will help bring peace of mind to families, allow for children affected by food
allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for
death from accidental procedure. The approximate healthcare burden per patient is $3,000-4,000 per year.
Moonlight Therapeutics is developing a targeted way to administer peanut allergens into the top skin layers to
desensitize an allergic patient. Delivery is achieved using microneedles, which are minimally invasive and
painless. Importantly microneedles can deliver into topmost skin layers with high precision and reproducibility.
Because the delivery is in top and superficial skin layers, the approach is expected to produce little to no
systemic adverse reactions. We have demonstrated efficacy of our approach in a pre-clinical mouse model of
peanut sensitization. In this STTR Fast-Track grant application Moonlight Therapeutics has proposed aims that
will allow it to file an investigational new drug (IND) application with the FDA for first-in-human trials. In Phase
1, four aims are proposed to develop processes for producing peanut allergen proteins and coated MNs with
strict quality assurance and operating procedures that can be transferred to cGMP production. An efficacy
study in animals is also proposed in Phase 1. Appropriate milestones and success criteria have been
established for Phase-1. In Phase-2, four aims are proposed so as to perform non-GLP (good laboratory
practices) and GLP toxicity studies, and establish production under cGMP. In addition, animal studies will be
done to compare microneedles to a conventional skin patch. At the conclusion of Phase-2 an IND application
will be submitted to the FDA.
Overall, these studies will provide the foundation to support the development of a novel and safer peanut
allergy immunotherapy treatment.

## Key facts

- **NIH application ID:** 10125501
- **Project number:** 3R42AI143011-02S1
- **Recipient organization:** MOONLIGHT THERAPEUTICS, INC.
- **Principal Investigator:** Samirkumar Patel
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2019-04-01 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10125501

## Citation

> US National Institutes of Health, RePORTER application 10125501, Microneedle Based Targeted Allergen Specific Immunotherapy for Treatment of Peanut Allergies (3R42AI143011-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10125501. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*