Materials and methods for improving immune responses and skin and/or mucosal barrier functions
Inventors
Berkes, Eva A. • Monsul, Nicholas T. • BOEHM, Frederick T.
Assignees
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Publication Number
US-11564957-B2
Publication Date
2023-01-31
Expiration Date
Abstract
The subject invention provides compositions and methods for treating human dermatological conditions by employing a microbiome-centered treatment approach. Preferred embodiments of the invention provide pharmaceutical and cosmetic compositions, and the methods of using the same, comprising a strain of Lactobacillus fermentum bacterium, or bioactive extracts thereof, derived from human microbiota and capable of growing in biofilm phenotype.
Core Innovation
The invention is directed to a method of treating a pathological condition by administering to a subject in need of such treatment a therapeutically effective amount of a composition comprising a Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm, or a bioactive extract of said L. fermentum strain. The pathological condition is selected from psoriasis, ichthyosis, sarcoidosis, acne, dermatitis, burns, diaper rash, actinic keratosis, dermatomycoses, dermatosis, ectodermal dysplasia, atopic dermatitis, contact dermatitis, sebortheic dermatitis, vulgaris and filaggrin deficiency, and bacterial infections of a mucosal surface or skin.
The document states that the composition is used in microbiome-centered therapy using the PTA-122195 biofilm/planktonic-derived bioactive extract concept. The bioactive extract activity is described as inhibiting pathogenic biofilm growth/adhesion and promoting detachment while promoting commensal biofilm growth, as exemplified by methicillin-resistant Staphylococcus aureus versus Staphylococcus epidermidis.
The composition enhances skin barrier function by upregulating skin barrier proteins, including filaggrin, loricrin, involucrin, and junction/desmosomal proteins. The composition also enhances skin innate immune function by modulating innate immune peptides and inflammatory cytokines, including human beta defensins HβD-1/2/3 and cathelicidin LL-37, and inflammatory cytokines such as IL-1α, IL-4, IL-13, and TSLP.
Claims Coverage
The independent claim is directed to a method of treating a pathological condition using a therapeutically effective amount of a composition comprising a Lactobacillus fermentum strain (Accession No. PTA-122195) grown as a biofilm, or a bioactive extract of the strain. The claim set includes 7 inventive features that refine the indications and specify biological mechanisms including skin barrier protein upregulation and skin innate immune modulation via innate immune peptides and inflammatory cytokines.
Therapeutic composition of PTA-122195 biofilm or bioactive extract
Administering, to a subject in need of such treatment, a therapeutically effective amount of a composition comprising a Lactobacillus fermentum strain having an Accession No. PTA-122195 grown as a biofilm, or a bioactive extract of said L. fermentum strain.
Pathological condition selection for skin disorders, filaggrin deficiency, and mucosal or skin bacterial infections
Treating a pathological condition selected from psoriasis, ichthyosis, sarcoidosis, acne, dermatitis, burns, diaper rash, actinic keratosis, dermatomycoses, dermatosis, ectodermal dysplasia, atopic dermatitis, contact dermatitis, sebortheic dermatitis, vulgaris and filaggrin deficiency, and bacterial infections of a mucosal surface or skin.
Skin innate immune enhancement by modulating innate immune peptides and inflammatory cytokines
Enhancing a skin innate immune function by modulating the expression of one or more innate immune peptides and/or modulating the expression of inflammatory cytokines in connection with the method.
Innate immune peptides selected from human beta defensins and cathelicidin
Selecting the innate immune peptide(s) from human beta defensin 1, human beta defensin 2, human beta defensin 3, and human cathelicidins (LL-37).
Inflammatory cytokines selected from IL-1α, IL-4, IL-13, and TSLP
Selecting the inflammatory cytokine(s) from interleukin-1 alpha, interleukin-4, interleukin-13, and thymic stromal lymphoproteins (TSLP).
MRSA infection treatment
Using the method to treat an infection caused by methicillin-resistant Staphylococcus aureus (MRSA).
Skin barrier function enhancement by upregulating barrier protein expression
Enhancing skin barrier function by upregulating expression of skin barrier proteins selected from filaggrin 1, filaggrin 2, loricrin, involucrin, junction proteins and desmosomal proteins.
Overall claim coverage centers on administering a composition containing Lactobacillus fermentum (Accession No. PTA-122195) grown as a biofilm or a bioactive extract, for skin and mucosal pathological conditions including bacterial infections. Dependent claim features specify innate immune modulation through defined innate immune peptides and inflammatory cytokines, and skin barrier enhancement via upregulation of barrier proteins including filaggrin, loricrin, involucrin, and junction/desmosomal proteins, with an example indication of MRSA infection.
Stated Advantages
Inhibiting pathogenic biofilm growth/adhesion and promoting detachment while promoting commensal biofilm growth.
Enhancing skin barrier function by upregulating skin barrier proteins.
Enhancing skin innate immune function by modulating innate immune peptides and inflammatory cytokines.
Documented Applications
Treating pathological conditions including psoriasis, ichthyosis, sarcoidosis, acne, dermatitis, burns, diaper rash, actinic keratosis, dermatomycoses, dermatosis, ectodermal dysplasia, atopic dermatitis, contact dermatitis, sebortheic dermatitis, vulgaris and filaggrin deficiency.
Treating bacterial infections of a mucosal surface or skin, including an infection caused by methicillin-resistant Staphylococcus aureus (MRSA).
Treating conditions associated with filaggrin deficiency and improving skin barrier protein expression such as filaggrin, loricrin, involucrin, and junction/desmosomal proteins.
Modulating skin innate immune function by affecting innate immune peptides (human beta defensins and cathelicidins (LL-37)) and inflammatory cytokines (IL-1α, IL-4, IL-13, and TSLP).
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