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

Description

ABSTRACT SUMMARY Food Allergy is a serious and sometimes fatal condition affectingmillion people in the US for which there currently no cureThere are nearlyER visits for food induced anaphylaxis andfood allergy fatalities in the US every yearAllergen avoidance and rescue epinephrine are the only established management but risk of accidental exposure is very highespecially for childrenIgE is central to anaphylaxis in food allergy howevera therapeutic strategy targeting IgE production has not been reportedGeneral Nutraceutical Technology LLCGNTspun out of Mount Sinai is a biotech startup based in ElmsfordNY dedicated to development of botanical food allergy therapiesWe have developed an innovative natural product nanoparticle formulation of berberine encapsulated with heparin and chitosanNIT XIn murine models of peanut allergywe observed profoundselective and lasting abrogation of peanut specific IgE which importantly was accompanied by reduction in long lived IgE plasma cell numbersWe plan to commercialize NIT X as an oral syrup formulation designed to treat food allergyFeasibility of NIT X development will be demonstrated in thespecific aims of this PhaseSBIR proposalIn Aimwe hypothesize that NIT X will be effective in a humanized mouse model peanut allergy and concurrent peanut tree nut allergy in C H HeJ miceIn Aimwe will determine preclinical bioavailabilitypharmacokinetics and tissue distributionCompletion of these Aims will facilitate human clinical trials planned for Phase II studiesSuccessful development of NIT X will provide an innovative and effective solution to life long food allergy for millions of patientsEffective abolition of long lived antigen specific plasma cells by NIT X breaks a long standing barrier in the field of therapeutic medicine for food allergies and holds strong scientific premise Narrative Food Allergy is a serious and sometimes fatal condition affecting nearlymillion people in the US for which there currently no cureGNTLLCa biotech startup based in ElmsfordNY has developed an innovative berberine based nanoparticle NIT X which in preclinical murine studies causes profoundselective and lasting abrogation of IgE and completely protects from anaphylaxisUnique ability of NIT X to reduce IgE producing cells makes it a potentially break through treatment for food allergy