Compositions for delivery of food allergens to the stomach
Inventors
Benhamou, Pierre-Henri • Dupont, Christophe • KOPPELMAN, STEFAN (JOHAN) • Martin, Laurent • BROCHARD, HERVÉ • Foucher, Estelle
Assignees
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Publication Number
US-10300133-B2
Publication Date
2019-05-28
Expiration Date
Abstract
The invention relates to novel compositions and methods for diagnosing or treating food allergies. The invention particularly discloses new approaches for delivering food allergens to allergic patients by oral administration of formulations which dissolve and release proteins in the stomach. The invention allows the treatment of food allergies by delivering food allergens to the gut immune system with controlled exposure of the esophagus or oral cavity. The invention also allows to perform food challenges to assess the threshold of clinical reactivity without exposing the esophagus and oral cavity. The invention may be used in any subject, particularly human subjects, and is applicable to any food allergen.
Core Innovation
The invention relates to an oral particulate pharmaceutical product suitable for oral administration of a peanut allergen. The particles include a neutral core surrounded by a first layer comprising heat treated peanut allergen, and the neutral core comprises a polyhydroxylated compound or a sugar.
The particles further comprise a stomach-labile coating layer that is stable at neutral pH and surrounds the first layer. The stomach-labile coating layer comprises cationic copolymers based on dimethylaminoethyl methacrylate, butyl methacrylate, methyl methacrylate, or mixtures thereof.
The formulation is characterized by controlled allergen delivery such that essentially all the heat treated peanut allergen is released in the stomach. It provides essentially no oral cavity dissolution and essentially all allergen release in the stomach, thereby limiting exposure of the esophagus and oral cavity compared with free allergen.
Claims Coverage
The document includes one independent claim directed to an orally administrable pharmaceutical peanut-allergen particulate product with three inventive features. Dependent claims refine the particle and layer composition and size constraints, and additional dependent claims cover downstream uses for delivering allergen to the stomach, determining reactivity, and inducing tolerance.
Stomach-labile coated particulate peanut-allergen product with neutral core
A pharmaceutical product suitable for oral administration of a peanut allergen, comprising particles of defined size, wherein the particles comprise a neutral core surrounded by a first layer comprising heat treated peanut allergen, and wherein the neutral core comprises a polyhydroxylated compound or a sugar; the particles further comprise a stomach-labile coating layer stable at neutral pH and comprising cationic copolymers based on dimethylaminoethyl methacrylate, butyl methacrylate, methyl methacrylate or mixtures thereof; and wherein the product releases essentially all the heat treated peanut allergen in the stomach.
Overall, the claim coverage focuses on a particulate oral peanut-allergen formulation built from a neutral core with a heat treated peanut allergen layer and a neutral-pH-stable stomach-labile cationic coating, producing essentially all allergen release in the stomach.
Stated Advantages
Improves DBPCFC reactivity testing without taste perception/false positives.
Induces tolerance via oral immunotherapy while aiming to reduce risks such as eosinophilic esophagitis by controlling esophageal exposure.
Documented Applications
Oral immunotherapy (OIT) to induce tolerance to a peanut allergen in a subject allergic to the peanut allergen.
DBPCFC reactivity testing to determine clinical reactivity thresholds using the described formulations.
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