METHODS AND COMPOSITIONS FOR CHANGING THE COMPOSITION OF THE SKIN MICROBIOME USING COMPLEX MIXTURES OF BACTERIAL STRAINS

• US 20190314428A1
• Filed: 10/19/2017
• Published: 10/17/2019
• Est. Priority Date: 10/19/2016
• Status: Active Grant

• Current Assignee: S-Biomedics
• Original Assignee: S-Biomedics
• Inventors: Patzold, Bernhard, Guell, Marc
• Granted Patent: US 11,541,081 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 38/011 from plants
• CPC Class Codes: A61K 38/018 from milk
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/08 Antiseborrheics
• CPC Class Codes: A61P 17/10 Anti-acne agents

Abstract

Aspects of the invention relate to compositions comprising two or more live bacterial strains for topical administration to the skin, wherein the two or more live bacterial strains are Propionibacterium acnes (P. acnes) bacterial strains, and methods for use.

Claims

1. A composition for topical administration to the skin comprising a live Propionibacterium acnes (P. acnes) bacterial strain, wherein the live P. acnes bacterial strain is a P. acnes single-locus sequence typing (SLST) type K8 strain, and wherein the composition further comprises one or more of a thickener, buffer, or carrier.

8. The composition of claim 1, wherein the thickener comprises hydroxyethyl cellulose, starch, gum, kaolin, hydrated aluminum silicate, fumed silica, carboxyvinyl polymer, sodium carboxymethyl cellulose, ethylene glycol monostearate, or sodium alginate.

9. The composition of claim 8, wherein the hydroxyethyl cellulose comprises NATROSOL®

hydroxyethylcellulose (HEC).

10. The composition of claim 1, wherein the concentration of the thickener is from about 1%-5%.

13. The composition of claim 1, wherein the composition further comprises a P. acnes SLST type C3 strain.

16. The composition of claim 1, wherein the composition includes at least 10⁴ colony-forming units per milliliter (CFU/ml) of the live P. acnes bacterial strain.

18. The composition of claim 1, wherein the composition is in the form of a gel, cream, ointment lotion, or powder and/or wherein the composition is part of a two-component dispensing system.

19. The composition of claim 1, further comprising an additional P. acnes bacterial strain selected from the group consisting of:

D1, H1, H2, H3, K1, K2, K4, K6, K9, and L1 SLST type strains.

53. The composition of claim 1, wherein the composition does not include a ribotype 6 (RT6) strain of P. acnes.

54. The composition of claim 1, wherein the composition does not include a Phylotype III strain of P. acnes.

55. The composition of claim 1, wherein the composition is stable at room temperature for at least three months.

56. The composition of claim 1, wherein the composition is not naturally occurring.

57. A method comprising administering the composition of claim 1 to a subject, optionally wherein the subject is a human subject.

58. The method of claim 57, wherein the method comprises improving the appearance of the skin and/or maintaining healthy skin.

59. The method of claim 57, wherein the method comprises treating or preventing a condition selected from the group consisting of:

acne, oily skin, progressive macular hypomelanosis, dandruff, atopic eczema, atopic dermatitis and rosacea.

60. The method of claim 57, wherein the method comprises administering the composition to a subject who also receives or has previously received treatment with a disinfectant or an antibiotic.

2-7. -7. (canceled)

11-12. -12. (canceled)

14-15. -15. (canceled)

17. (canceled)

20-52. -52. (canceled)

61. A kit comprising a container housing freeze-dried live bacteria, wherein the freeze-dried live bacteria comprise a Propionibacterium acnes (P. acnes) single-locus sequence typing (SLST) type K8 strain.

62. The kit of claim 61, wherein the kit further comprises a disinfectant or antibiotic.

63. The kit of claim 61, wherein the kit further comprises a P. acnes SLST type C3 strain.

64. A composition for topical administration to the skin comprising two or more different live Propionibacterium acnes (P. acnes) bacterial strains, wherein the live P. acnes single-locus sequence typing (SLST) type K8 strain and a live P. acnes SLST type C3 strain, optionally wherein the composition further comprises one or more of a thickener, buffer, or carrier.