# IgE Suppressing Berberine Nanomedicine for Treatment of Food Allergies

> **NIH NIH R44** · GENERAL NUTRACEUTICAL TECHNOLOGY, LLC · 2024 · $894,193

## Abstract

ABSTRACT
 Food allergy (FA) has rapidly increased over 2 decades affecting 32 million Americans, with annual costs
of $25 billion. FA anaphylaxis, a potentially life-threatening condition, increased 200-400% in children from
toddlers to teens.10 Peanut/ tree nut and sesame allergy often co-exist, last a lifetime, cause severe reactions,
and there is currently no cure. Common treatments, either prophylactic i.e., food avoidance, or therapeutic i.e.,
food allergen oral immunotherapy are limited and impractical. Safe, effective, and non-food restricted
therapeutics are needed. FA is primarily mediated by food protein specific immunoglobulin E. Persistent IgE
caused by long-lived plasma cells (IgE+LPC) is a significant barrier to FA mitigation. General Nutraceutical
Technology LLC (GNT), a NY-based biotechnology startup, is building on groundbreaking research for FA
started at Icahn School of Medicine at Mount Sinai. Our oral product “NIT-X” contains the small molecule
compound berberine captured by nanoparticles. It significantly increased bioavailability, showed excellent
preclinical safety and nearly 100% reduction of PN-IgE and protection against anaphylaxis in animal model of
peanut and tree nut allergies, associated with suppressing IgE+ plasma cells/B cells, reducing IL-4, increasing
IFN-γ, inducing a distinct B cell transcriptomic profile. We hypothesize that by restoring balanced immunity.
NIT-X will be a potentially novel non-food restricted therapeutic for severe and multiple FAs. The goals of this
SBIR Phase II are generating robust NIT-X Chemistry, Manufacturing and Control (CMC), along further
preclinical pharmacokinetic (PK), toxicology and pharmacology data, and file the phase Ia clinical study. We
will conduct 4 Specific Aims: #1 Generating NIT-X CMC data, characterization of product and preclinical PK
profile; #2. Further generation of data on NIT-X preclinical toxicology; #3. Investigate dose efficacy of NIT-X in
murine models. #4. File phase Ia clinical trial as a sub-program to an ongoing parent botanical IND. Solid SBIR
phase I feasibility data and strong team and design for phase II study enable GNT to generate rigorous date for
CMC, preclinical PK, safety, and efficacy for obtaining approval of IND for a subproject to the current IND for
clinical trials with NIT-X, towards commercialization for treating FA.

## Key facts

- **NIH application ID:** 10840330
- **Project number:** 5R44AI177183-02
- **Recipient organization:** GENERAL NUTRACEUTICAL TECHNOLOGY, LLC
- **Principal Investigator:** Xiu-Min Li
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $894,193
- **Award type:** 5
- **Project period:** 2023-05-11 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10840330

## Citation

> US National Institutes of Health, RePORTER application 10840330, IgE Suppressing Berberine Nanomedicine for Treatment of Food Allergies (5R44AI177183-02). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10840330. Licensed CC0.

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