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IgE Suppressing Berberine Nanomedicine for Treatment of Food Allergies

抑制 IgE 的小檗碱纳米药物治疗食物过敏

基本信息

批准号：
10698900
负责人：
Xiu-Min Li
金额：
$ 92.02万
依托单位：
GENERAL NUTRACEUTICAL TECHNOLOGY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-11 至 2025-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10698900
关键词：
Accidents Acute Adult Affect Age Amendment American Anaphylaxis Animal Model Annual Reports Antibodies Area Under Curve B-Lymphocytes Berberine Biochemistry Biological Availability Biotechnology Body Surface Botanicals Categories Chemistry Child Chronic Clinical Clinical Research Clinical Trials Data Dose Double-Blind Method Drug Kinetics Encapsulated Epithelial Cells FDA approved Food Food Hypersensitivity Generations Goals Heavy Metals Hematology Histamine Histology Hypersensitivity IgE Immunity Immunoglobulin A Immunoglobulin G Immunosuppression Individual Industry Inflammation Interferon Type II Interleukin-10 Interleukin-4 Investigational Drugs Laboratories Life Marketing Mediating Morbidity - disease rate Mus Nut Hypersensitivity Nutraceutical Nuts Oral Outcome Parents Persons Pesticides Pharmaceutical Preparations Pharmacology Pharmacology and Toxicology Phase Phase Ia Clinical Trial Placebo Control Placebos Plasma Plasma Cells Preparation Production Proteins Reaction Research Residual state Risk Safety Sesame - dietary Small Business Innovation Research Grant Solid Technology Teenagers Testing Therapeutic Time Toddler Toxicology Trees Work absorption anti-IgE commercialization common treatment cost drug development food allergen food avoidance high risk immunoreaction innovation intestinal epithelium manufacture mast cell medical schools meetings microbial mortality mouse model nano nanomedicine nanoparticle novel novel therapeutics omalizumab oral immunotherapy phase 1 designs phase 2 designs phase 2 study phase I trial pre-clinical preclinical safety programs prophylactic protective effect small molecule transcriptomics

项目摘要

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.

摘要