AMMONIA OXIDIZING BACTERIA FOR TREATMENT OF ACNE

• US 20160151427A1
• Filed: 10/13/2015
• Published: 06/02/2016
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: AOBiome LLC (AOBiome Therapeutics, Inc.)
• Original Assignee: AOBiome LLC (AOBiome Therapeutics, Inc.)
• Inventors: Whitlock, David R., Jamas, Spiros, Weiss, Larry
• Granted Patent: US 9,738,870 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 8/99 from microorganisms other than algae or fungi, e.g. protozoa or bacteria
• 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: A61L 15/36 containing microorganisms
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/10 Anti-acne agents
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 : Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/08 : Vasodilators for multiple indications
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: A61Q 15/00 : Anti-perspirants or body deodorants deodorisation of air A61L9/00
• CPC Class Codes: A61Q 17/04 : Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin
• CPC Class Codes: A61Q 19/02 : for chemically bleaching or whitening the skin
• CPC Class Codes: A61Q 19/04 : for chemically tanning the skin topical sun or radiation screening or tanning preparations A61Q17/04
• CPC Class Codes: C07K 14/195 : from bacteria
• CPC Class Codes: C12N 1/00 : Microorganisms, e.g. protozoa; Compositions thereof medicinal preparations containing material from protozoa, bacteria or viruses A61K35/66, from algae A61K36/02, from fungi A61K36/06; preparing medicinal bacterial antigen or antibody compositions, e.g. bacterial vaccines, A61K39/00; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
• CPC Class Codes: C12N 1/20 : Bacteria; Culture media therefor
• CPC Class Codes: C12N 1/205 : Bacterial isolates
• CPC Class Codes: C12Q 1/02 : involving viable microorganisms
• CPC Class Codes: C12Q 1/689 : for bacteria
• CPC Class Codes: C12R 2001/01 : Bacteria or Actinomycetales ; using bacteria or Actinomycetales

Abstract

A method for treating a skin disorder, e.g., acne, e.g. acne vulgaris, in a subject is provided. The method comprises administering, e.g., applying, e.g., topically administering, ammonia oxidizing bacteria, e.g., a preparation comprising ammonia oxidizing bacteria, to a surface of the subject. Preparations comprising ammonia oxidizing bacteria for treating such skin disorder, e.g., acne, e.g. acne vulgaris in a subject are also provided.

Claims

1. A method of treating a skin disorder, e.g., acne, e.g. acne vulgaris, of a subject comprising:

administering, e.g., applying, e.g., topically administering, ammonia oxidizing bacteria, e.g., a preparation comprising ammonia oxidizing bacteria, to a surface of the subject.

2. The method of claim 1, wherein an amount and a frequency of administration, e.g., application, is sufficient to reduce the amount or concentration of pathogenic bacteria, e.g., Propionibacterium acnes, on the surface of the subject.

4. The method of claim 1, wherein the skin disorder is acne, e.g., acne vulgaris.

5. The method of claim 4, wherein administering provides for treatment of inflammatory lesions, e.g., papules, pustules, cysts/nodules.

6. The method of claim 5, wherein administering provides for treatment of non-inflammatory lesions, e.g., open comedones, closed comedones.

8. The method of claim 5, wherein administering provides for treatment or improvement of one or more of erythema, edema, scaling, stinging, burning, and itching.

9. The method of claim 5, wherein administering provides for treatment or improvement of one or more of oily appearance, pore appearance, radiance, blotchiness, skin tone evenness, visual smoothness, and tactile smoothness.

14. The method of claim 2, wherein an effective dose is about 0.1×

10⁹, 0.2×

10⁹, 0.3×

10⁹, 0.4×

10⁹, 0.5×

10⁹, 0.6×

10⁹, 0.7×

10⁹, 0.8×

10⁹, 0.9×

10⁹, 1.0×

10⁹, 1.2×

10⁹, 1.4×

10⁹, 1.5×

10⁹, 1.6×

10⁹, 1.8×

10⁹, 2.0×

10⁹, 2.2×

10⁹, 2.4×

10⁹, 2.6×

10⁹, 2.8×

10⁹, 3.0×

10⁹, 3.2×

10⁹, 3.4×

10⁹, 3.6×

10⁹, 3.8×

10⁹, 4.0×

10⁹, 4.2×

10⁹, 4.4×

10⁹, 4.6×

10⁹, 4.8×

10⁹, 5.0×

10⁹, 5.5×

10⁹, 6.0×

10⁹, 6.5×

10⁹, 7.0×

10⁹, 7.5×

10⁹, 8.0×

10⁹, 8.5×

10⁹, 9.0×

10⁹, 9.5×

10⁹, 10.0×

10⁹, 12×

10⁹, 14×

10⁹, 16×

10⁹, 18×

10⁹, 20×

10⁹, 25×

10⁹, 30×

10⁹, 40×

10⁹, 50×

10⁹ CFU.

17. The method of claim 1, further comprising determining whether the subject is in need of treating the skin disorder, e.g., determining whether the subject it in need of treating acne, e.g., acne vulgaris.

19. The method of claim 1, wherein the ammonia oxidizing bacteria, e.g., preparation comprising ammonia oxidizing bacteria may be in a form that may be capable of being aerosolized, sprayed or misted, i.e., in the form of a mist.

21. The method of claim 1, wherein the ammonia oxidizing bacteria, e.g., preparation of ammonia oxidizing bacteria may be ammonia oxidizing bacteria in a buffer solution, e.g., aqueous buffer solution.

23. The method of claim 21, wherein the buffer solution e.g., aqueous buffer solution, consisting essentially of disodium phosphate and magnesium chloride, for example, 50 mM Na₂HPO₄ and 2 mM MgCl₂ in water.

27. The method of claim 1, wherein the ammonia oxidizing bacteria is applied to any one or more of the face, neck, and scalp of the subject.

28. The method of claim 1, wherein the preparation comprises at least one of ammonia, ammonium salts, and urea.

30. The method of claim 1, wherein the preparation of ammonia oxidizing bacteria, further comprises an excipient, e.g., one of a pharmaceutically acceptable excipient or a cosmetically acceptable excipient.

33. The method of claim 1, wherein the preparation is disposed in a powder, cosmetic, cream, stick, aerosol, e.g., mist, salve, wipe, or bandage.

37. The method of claim 1, wherein the preparation comprising ammonia oxidizing bacteria comprises about 10⁸ to about 10¹⁴ CFU/L ammonia oxidizing bacteria.

41. The method of claim 1, wherein the ammonia oxidizing bacteria is selected from the group consisting of Nitrosomonas, Nitrosococcus, Nitrosospira, Nitrosocystis, Nitrosolobus, Nitrosovibrio, and combinations thereof.

42. The method of claim 41, wherein the ammonia oxidizing bacteria is Nitrosomonas eutropha (N. eutropha).

43. The method of claim 42, wherein the ammonia oxidizing bacteria is N. eutropha D23, having ATCC accession number PTA-121157.

52. The method of claim 1, wherein the preparation is applied for about 7 to about 28 days.

60. The method of claim 1, wherein administering the ammonia oxidizing bacteria provides for a decrease in Propionibacterium acnes.

70. The method of claim 1, wherein administering the preparation provides for one or more of the following:

reduces inflammation of lesions, reduces the frequency of lesions, and decreases the presence of pathogenic bacteria, e.g., Propionibacterium acnes.

86. The method of claim 1, wherein an acne treatment selected from the group consisting of:

a topical retinoid, azaelaic acid, salicylic acid, a topical antimicrobial, an oral antibiotic, benzoyl peroxide, an oral anti-androgen, an oral isotretinoin, and combinations thereof. is administered to the subject.

94. A preparation comprising ammonia oxidizing bacteria as recited in claim 1 for the treatment of a skin condition, e.g., acne, e.g., acne vulgaris.

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