Compositions and methods for the treatment or the prevention of E. coli infections and for the eradication or reduction of E. coli surfaces

• US 9,895,427 B2
• Filed: 05/15/2015
• Issued: 02/20/2018
• Est. Priority Date: 01/06/2009
• Status: Active Grant

• Current Assignee: Galenagen, LLC
• Original Assignee: Galenagen, LLC
• Inventors: Fallon, Joan M., Heil, Matthew, Fallon, James J.
• Primary Examiner(s): Carlson, Karen Cochrane
• Assistant Examiner(s): Tichy, Jennifer M. H.
• Application Number:
  US14/713,221
• Publication Number:
  US 20150246104A1
• Time in Patent Office: 1,012 Days
• Field of Search: None
• CPC Class Codes: A01N 63/50 Isolated enzymes; Isolated proteins peptides A01N37/46
• 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 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/12 Antidiarrhoeals
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 31/02 Local antiseptics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Compositions and methods for treating or preventing E. coli infections are provided. The compositions can be formulated as pharmaceutical compositions or as disinfectants, sanitizers, detergents or antiseptics, and can be used to eradicate or reduce E. coli populations and thereby treat or prevent infection by E. coli. The compositions include one or more digestive enzymes, e.g., one or more protease, lipases, and amylases. Methods of use of the compositions are also provided.

Claims

1. A method for treating diarrhea caused by an Escherichia coli (E. coli) infection in an individual, comprising orally administering to the individual a bactericidal pharmaceutical composition that consists of digestive enzymes and one or more pharmaceutically acceptable excipients, wherein the digestive enzymes comprise a protease, an amylase and a lipase, wherein the pharmaceutical composition is bactericidal for E. coli, and wherein the pharmaceutical composition is formulated for oral administration.

2. The method of claim 1, wherein the E. coli is a Shiga toxin-producing E. coli (STEC), an Enterotoxigenic E. coli (ETEC) or an Enteropathogenic E. coli (EPEC).

3. The method of claim 1, wherein the digestive enzymes comprise a mixture of proteases comprising chymotrypsin and trypsin.

4. The method of claim 1, wherein the protease and lipase in the pharmaceutical composition in United States Pharmacopoeia (U.S.P.) units are present in a ratio of from about 1:

1 to about 20;

1.

5. The method of claim 1, wherein the individual is a human, a ruminant, a pig or a bird.

6. The method of claim 1, wherein the digestive enzymes are microbial enzymes, plant enzymes, or are synthetic.

7. The method of claim 1, wherein the digestive enzymes are animal enzymes.

8. The method of claim 7, wherein the digestive enzymes are animal enzymes from a pig pancreas.

9. The method of claim 1, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of about 4:

1, about 7;

1, about 10;

1 or about 12;

1.

10. The method of claim 9, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of about 4:

1.

11. The method of claim 9, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of about 7:

1.

12. The method of claim 9, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of about 10:

1.

13. The method of claim 9, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of about 12:

1.

14. The method of claim 1, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of from about 4:

1 to about 10;

1.

15. The method of claim 1, wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of a pill, a tablet, a capsule, a caplet, a sprinkle, an emulsion, a powder, a liquid, a gel and a combination thereof.

16. The method of claim 1, further comprising administering a beta-lactam antibiotic to the individual.

17. The method of claim 2, wherein the pharmaceutical composition is effective against a STEC.

18. The method of claim 2, wherein the pharmaceutical composition is effective against an ETEC.

19. The method of claim 2, wherein the pharmaceutical composition is effective against an EPEC.

20. The method of claim 6, comprising the microbial enzymes, wherein the microbial enzymes are fungal enzymes.

21. The method of claim 1, wherein administration of the pharmaceutical composition to the individual kills over 50% of E. coli causing the diarrhea.

22. The method of claim 1, wherein the one or more pharmaceutically acceptable excipients comprise a binder, a lubricant, a diluent, a glidant, a disintegrating agent, a coloring agent, a sweetening agent, a flavoring agent, a wetting agent, or a combination thereof.