24 Feb Peanut Allergy: Painless Microneedle Patch Has Potential To Induce Desensitization
MedicalResearch.com Interview with:
Authors: Mike Kulis, Johanna Smeekens, Edwin Kim, Vladimir Zarnitsyn, Samirkumar Patel
MedicalResearch.com: What is the background for this study?
Response: Peanut allergy is an IgE-mediated disease affecting approximately 2% of young children in the United States. Over the past decade, various forms of immunotherapy have been investigated with the goal of repeated daily allergen exposure leading to a desensitized state. One of these therapies, oral immunotherapy, or OIT, received FDA approval for treating peanut allergy in January 2020 with Aimmune’s Palforzia drug. While OIT effectively induces desensitization in a majority of patients, there is a substantial burden related to side effects, with an ever-present risk of systemic anaphylaxis.
MedicalResearch.com: What are the main findings?
Response: In our study, we utilized a novel platform developed by Moonlight Therapeutics and tested at UNC Chapel Hill. The platform uses a patch that delivers peanut proteins into the top layer of the skin using tiny microneedles. The delivery takes only a few minutes and the microneedle application with no drug has shown to be relatively painless in healthy adults (Ref1). Our testing in mice demonstrated that three applications of low doses of peanut proteins (5 µg) once per week induced peanut-specific antibody responses. Additionally, we performed a study demonstrating that the major peanut allergen, Ara h 2, was not found in blood serum 45 or 120 minutes post-microneedle application, whereas an equivalent dose of peanut protein given by subcutaneous injection led to much higher levels of Ara h 2 in circulation.
MedicalResearch.com: What should readers take away from your report?
Response: Microneedle patches loaded with peanut proteins were able to induce robust immunologic responses in mice using low doses of peanut protein. Unlike subcutaneous injection of peanut proteins, delivery of peanut proteins via microneedles resulted in nearly undetectable levels of allergen in systemic circulation. These findings tell us that this novel microneedle based approach has the potential to generate a positive immune response that may not lead to severe systemic allergic reactions. If this profile translates across to humans, this could be an approach that would allow for a safe, and convenient way to desensitize people to peanut and other food allergies.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Although this data is promising and past research has demonstrated that this approach can lead to desensitization in mice (Ref2) additional data to confirm these findings are needed. The next steps for our team will be to understand the mechanism by which this occurs. Moonlight Therapeutics is pursuing preclinical safety studies to be presented to the FDA so that they can evaluate this therapy in peanut allergic subjects in human clinical trials.
MedicalResearch.com: Is there anything else you would like to add?
Response: Food allergy is a life-threatening disease and additional therapies are needed to address a large unmet medical need. We are excited to be on the cutting-edge of developing a new platform that could be used to treat peanut and other types of food allergies, such as those to egg, milk, tree nuts, and shellfish.
Disclosures: Samirkumar Patel and Vladimir Zarnitsyn, are employees of and have a financial interest in Moonlight Therapeutics, a company that is developing a therapy for peanut allergies using the technology discussed in this research.
Ref 1: Gill, Harvinder S., Donald D. Denson, Brett A. Burris, and Mark R. Prausnitz. 2008. “Effect of Microneedle Design on Pain in Human Volunteers.” Clinical Journal of Pain 24(7): 585–94.
Ref 2: Shakya, Akhilesh Kumar et al. 2019. “Microneedles Coated with Peanut Allergen Enable Desensitization of Peanut Sensitized Mice.” Journal of Controlled Release 314(October): 38–47. https://doi.org/10.1016/j.jconrel.2019.09.022.
ABSTRACT ONLY| VOLUME 147, ISSUE 2, SUPPLEMENT , AB237, FEBRUARY 01, 2021
Peanut protein-loaded microneedle patches are immunogenic and distinct from subcutaneous delivery
Michael Kulis, PhD, Johanna Smeekens, PhD, Edwin Kim, MD MS FAAAAI, Vladimir Zarnitsyn, PhD , Samirkumar Patel, PhD
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