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Publication Number

US-11931411-B2

Patent

Publication Date

2024-03-19

Expiration Date


Abstract

The present application relates to a method for desensitization of allergic patients. More specifically it relates to an epicutaneous desensitization method, applicable to any type of allergens and of patients. The method of the invention is essentially non-invasive and does not require the use of adjuvants. Further, it may be easily applied and monitored by the actual patient.

Core Innovation

The invention relates to an epicutaneous desensitization method for a subject allergic to an allergen. The method generates an immune reaction by applying an allergen dose without an adjuvant onto an intact region of skin, and the immune reaction and the resulting exposure are used to achieve desensitization of the subject.

The core approach repeatedly applies the allergen, also without an adjuvant, to an intact region of the skin. A dose, frequency or application time is adapted to sustain the immune reaction, and the sustained reaction from the exposure leads to desensitization. The sustained immune reaction is oriented toward a tolerogenic immune response in the described concept.

The allergen is applied using a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin. The described system includes a device and formulation scope intended to sustain and control local skin inflammation while avoiding adjuvants, with described monitoring of the cutaneous reaction during treatment.

Claims Coverage

Independent claim clm-00001 defines a method for epicutaneous desensitization with two core inventive requirements: adjuvant-free allergen exposure on intact skin to generate an immune reaction, and repeated adjuvant-free re-application using a regimen adapted to sustain the immune reaction to achieve desensitization. A further requirement specifies occlusive device-mediated contact and a defined allergen dose range per device surface area.

Adjuvant-free epicutaneous exposure on intact skin to generate an immune reaction

Epicutaneously exposing the subject to the allergen and generating an immune reaction by applying a dose of the allergen, without an adjuvant, onto an intact region of skin of the subject.

Repeated adjuvant-free application adapted to sustain the immune reaction leading to desensitization

Repeatedly applying the allergen, without an adjuvant, to an intact region of the skin at a dose, frequency or for an application time adapted to sustain the immune reaction, the exposure and sustained reaction leading to desensitization.

Occlusive cutaneous device ensuring contact and dose specified per device surface area

Applying the allergen by a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin, wherein the dose of allergen is comprised between 0.1 and 1,000 μg/cm2 of a surface area of the device.

Overall, the claim set centers on epicutaneous allergen desensitization without an adjuvant by generating and sustaining a local immune reaction through repeated adjuvant-free allergen application on intact skin, delivered via an occlusive cutaneous device with a specified dose per device surface area.

Stated Advantages

Avoids adjuvants while enabling epicutaneous desensitization.

Desensitization is achieved by sustaining the immune reaction using a regimen adapted to dose, frequency or application time.

Sustained and controlled local cutaneous inflammatory reaction is monitored during treatment.

Documented Applications

Epicutaneous desensitization of a subject allergic to an allergen.

Food allergen or respiratory allergen desensitization using the described method (as defined by dependent claim categories).

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