GENERAL NUTRACEUTICAL TECHNOLOGY LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

ABSTRACTFood 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.