US-12622934-B2 - Pharmaceutical composition for preventing or treating atopic disease containing Faecalibacterium prausnitzii strain

Abstract

A pharmaceutical composition effective for the prevention or treatment of atopic disease is disclosed. The pharmaceutical composition contains a Faecalibacterium prausnitzii EB-FPDK11 strain or a culture or dried product thereof. While traditional probiotics generally have an insignificant therapeutic effect for atopic disease, the pharmaceutical composition of the present invention exhibits a preventive or therapeutic effect on atopic disease at the same level as that of steroid-based drugs, and thus is not only promising as pharmabiotics, but also useful in the development of food and cosmetics.

Inventors

• Jae-Gu SEO
• Joo-Hyun SHIN
• Dokyung LEE
• Yoonmi LEE
• Seo Yul JANG
• Hye Rim BYEON

Assignees

• ENTEROBIOME INC.

Dates

Publication Date

20260512

Application Date

20210226

Priority Date

20200826

Claims (16)

1. 1 . A composition containing a culture or a dried product of an isolated Faecalibacterium prausnitzii EB-FPDK11 strain (KCCM12621P) as an active ingredient, formulated with at least one pharmaceutically acceptable additive selected from the group consisting of wetting agents, sweetening agents, flavoring agents, binders, disintegrants, coating agents, lubricants, and preservatives.
2. 2 . The composition of claim 1 , wherein the Faecalibacterium prausnitzii EB-FPDK11 strain has the 16s rRNA sequence set forth in SEQ ID NO: 1.
3. 3 . The composition of claim 1 , wherein the Faecalibacterium prausnitzii EB-FPDK11 strain is live or pasteurized.
4. 4 . The composition of claim 1 , further containing a vitamin or an immunosuppressant.
5. 5 . The composition of claim 4 , wherein the immunosuppressant is selected from the group consisting of a calcineurin inhibitor selected from cyclosporine, tacrolimus, pimecrolimus and ISA (TX) 247; rapamycin; a Type IV phosphodiesterase (Type IV PDE) inhibitor; mycophenolate mofetil; and dexamethasone.
6. 6 . The composition of claim 1 , comprising as the active ingredient the Faecalibacterium prausnitzii EB-FPDK11 strain in an amount of 10 8 to 10 12 CFU, or pasteurized or inactivated Faecalibacterium prausnitzii EB-FPDK11 derived from the culture of the isolated Faecalibacterium prausnitzii EB-FPDK11 strain containing 10 8 to 10 12 CFU.
7. 7 . The composition of claim 1 , wherein the composition is for use in the treatment or prevention of an atopic disease selected from the group consisting of asthma, atopic dermatitis, urticaria, allergic rhinitis, anaphylaxis, or food allergy.
8. 8 . A method for preventing or treating atopic disease in a subject in need thereof, comprising administering a composition comprising an isolated Faecalibacterium prausnitzii EB-FPDK11 strain (KCCM12621P) as an active ingredient to the subject.
9. 9 . The method of claim 8 , wherein the Faecalibacterium prausnitzii EB-FPDK11 strain has the 16s rRNA sequence set forth in SEQ ID NO: 1.
10. 10 . The method of claim 8 , wherein the Faecalibacterium prausnitzii EB-FPDK11 strain are is live or pasteurized.
11. 11 . The method of claim 8 , wherein the composition further comprises a vitamin or an immunosuppressant.
12. 12 . The method of claim 11 , wherein the immunosuppressant is selected from the group consisting of: a calcineurin inhibitor selected from cyclosporine, tacrolimus, pimecrolimus and ISA (TX) 247; rapamycin; a Type IV phosphodiesterase (Type IV PDE) inhibitor; mycophenolate mofetil; and dexamethasone.
13. 13 . The method of claim 8 , wherein the composition comprises as the active ingredient the Faecalibacterium prausnitzii EB-FPDK11 strain in an amount of 10 8 to 10 12 CFU, or pasteurized or inactivated Faecalibacterium prausnitzii EB-FPDK11 derived from the culture of the isolated Faecalibacterium prausnitzii EB-FPDK11 strain containing 10 8 to 10 12 CFU.
14. 14 . The method of claim 8 , wherein the atopic disease is asthma, atopic dermatitis, urticaria, allergic rhinitis, anaphylaxis, or food allergy.
15. 15 . The method of claim 8 , wherein the composition is a pharmaceutical composition, a dietary supplement, a food, or a cosmetic composition.
16. 16 . A health functional food for preventing or ameliorating atopic disease containing a culture or dried product of an isolated Faecalibacterium prausnitzii EB-FPDK11 strain (KCCM12621P) as an active ingredient, formulated with at least one nutritionally acceptable additive selected from the group consisting of wetting agents, sweetening agents, flavoring agents, binders, disintegrants, coating agents, lubricants, and preservatives.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a National Stage of International Application No. PCT/KR2021/002433 filed Feb. 26, 2021, claiming priority based on Korea Patent Application No. 10-2020-0107619 filed Aug. 26, 2020. INCORPORATION BY REFERENCE OF SEQUENCE LISTING The content of the electronically submitted sequence listing, file name: Q284319_Sequence_Listing_As_Filed.txt; size: 3,647 bytes; and date of creation: Jan. 20, 2023, filed herewith, is incorporated herein by reference in its entirety. TECHNICAL FIELD The present invention relates to a pharmaceutical composition for preventing or treating atopic disease, and more particularly to a pharmaceutical composition for preventing or treating atopic disease containing a Faecalibacterium prausnitzii EB-FPDK11 strain as an active ingredient. BACKGROUND ART In a strict sense, the term “atopy” refers to a predisposition to abnormally produce IgE in response to foreign substances entering the body from the outside. Thus, the team “atopy” is not the same as the team “allergy”, but these two terms are used interchangeably with substantially the same meaning. The clinical manifestations of such hypersensitivity are referred to as “atopic diseases” or “allergic diseases”. Traditionally, asthma, allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria, anaphylaxis, and food allergy and the like are classified as atopic diseases. Although the causes of atopic diseases known to date are not accurately identified, it is generally believed that genetic and immunological factors are involved in atopic diseases, and it is a common opinion of experts that other environmental and mental factors act to exacerbate atopic diseases. It is known that atopic diseases are not single diseases, but are multiple diseases, including atopic dermatitis, asthma and allergic rhinitis, which occur with atomic march or appear simultaneously. Among atopic diseases, atopic dermatitis is a chronic recurrent skin disease that affects newborns or children as well known to the public and may persist until adulthood. As the main symptom of atopic dermatitis, erythematous papules and blisters with severe itching occur in the acute phase, which is the initial stage of the disease, and they progress to exudative lesions that ooze when scratched, and at this time, secondary infections often occur. As the lesions progress, excoriations and papules occur in the subacute phase, and when the chronic phase is reached, lichenification occurs in which the skin becomes thickened. Atopic patients may receive repeated emergency care and hospitalization due to frequent recurrence and worsening symptoms, and have difficulty in normal school life, social life, or work life, resulting in mental pain, which may make normal life difficult. Since it is difficult to fundamentally cure atopic diseases and the symptoms thereof tend to be severe, symptoms of atopic diseases are controlled through appropriate treatment without aiming to cure the atopic diseases. Currently, atopic dermatitis is mainly treated by drug therapy such as steroids, antihistamines and antibiotics. The currently most widely used therapeutic agent is dexamethasone known as a steroidal drug. Steroidal drugs have excellent anti-inflammatory and immunosuppressive effects, but when they are used for a long period of time, a problem arises in that side effects such as skin weakness, systemic hormonal symptoms, and addictive symptoms occur. Antihistamines reduce itching symptoms by inhibiting the release of histamine from mast cells, but are used as a temporary measure and may cause side effects such as insomnia, anxiety and loss of appetite for a long time. As described above, synthetic drugs have severe side effects when used for a long period of time, and thus new treatments for atopy that have no side effects while being effective against atopic diseases are needed. As new treatments for atopy without side effects, new microbial drugs are attracting attention. Accordingly, the efficacy and function of probiotics are also attracting great attention. However, how microorganisms work in the body remains a considerable challenge, and in terms of efficacy, microorganisms merely help to keep the intestinal environment healthy, and hardly appear to exhibit certain pharmaceutical efficacy. Therefore, there is an urgent need to develop next-generation pharmabiotic treatments that have proven pharmaceutical efficacy for atopic diseases which are intractable diseases. PRIOR ART DOCUMENTS Patent Documents (Patent Document 1) KR20160069733 A(Patent Document 2) KR20130034764 A(Patent Document 3) KR101925135 B DISCLOSURE Technical Problem The present invention has been conceived to overcome the above-described problems, and an object of the present invention is to provide a pharmaceutical composition for preventing or treating atopic disease containing a Faecalibacterium prausnitzii strain (KCCM12621P) as an active ingredient