IP Library › Granted Patent US 12,263,192
Granted Patent B2
US 12,263,192 · App. 17/433,723 · Granted Apr 1, 2025

Compositions for management of disorders of the gastrointestinal tract

Inventors: Mark Grabowsky (New York, NY); Raymond J. Playford (Cobham, GB); Timothy W. Starzl (Boulder, CO); Tania Marchbank (Epsom, GB); Paul Kelly (Phoenix, AZ); Naheed Choudhry (Phoenix, AZ)
Assignee: PanTheryx, Inc.
A61K35/57A61K31/07A61K31/355A61K31/4415A61K31/51A61K31/593A61K31/714A61K33/04A61K33/18A61K33/34A61K33/42A61K35/20A61K39/39583A61K39/40A61K39/42A61P1/00A61K2039/55
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Quick Facts
Patent No.
US 12,263,192
App. No.
17/433,723
Granted
Apr 1, 2025
Kind
B2
Abstract

Effective and economical compositions and methods are disclosed for the treatment, and prevention of diseases and disorders associated with inflammation and/or damage to the gastrointestinal tract, including environmental enteric dysfunction. Compositions are provided comprising a synergistic combination of colostrum, immune egg, and optionally one or more additional active agents.

Claims (26)

1. A method of treating small intestinal bacterial overgrowth (SIBO) in a subject in need thereof, the method comprising administering the subject an effective amount of a composition comprising:

a) an egg antibody product comprising at least one specific avian antibody or antigen binding fragment thereof, and

b) a bovine colostrum;

wherein the administration results in treatment of the SIBO.

2. The method of claim 1 , wherein the bovine colostrum is whole bovine colostrum.

3. The method of claim 1 , wherein the egg antibody product is a whole immune egg.

4. The method of claim 3 , wherein the whole immune egg is a pasteurized raw dried whole immune egg powder.

5. The method of claim 1 , wherein the composition has a weight ratio of bovine colostrum to egg antibody product of about 10:1 to about 1:10, wherein the weight ratio is based on a dry weight equivalent.

6. The method of claim 1 , wherein the method further comprises co-administering an effective amount of additional active agent.

7. The method of claim 1 , wherein the composition further comprises an additional active agent.

8. The method of claim 1 , wherein the subject is a non-neonate human.

9. The method of claim 1 , wherein the effective amount of the composition comprises about 3 g to about 50 g of a combined weight of the egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

10. The method of claim 1 , wherein the specific avian antibodies or antigen binding fragments thereof, are specific for a pathogenic component from one, two, three, four, five, six, seven, or eight different pathogenic organisms.

11. The method of claim 1 , wherein the at least one specific avian antibody or antigen binding fragment thereof binds to an antigenic region of a pathogenic component selected from the group consisting of a pathogenic organism, a pathogen-related toxin, a pathogen-related adhesion element, and combinations thereof.

12. The method of claim 11 , wherein the pathogenic organism is selected from the group consisting of rotavirus, norovirus, calicivirus, enteric adenovirus, coronavirus, parvovirus, cytomegalovirus, astrovirus, herpes virus, Acanthamoeba spp., Aeromonas spp., Alternaria spp., Ancylostoma spp., Ascaris spp., Aspergillus spp., Bacillus spp., Byssochlamys spp., Campylobacter spp., Candida spp., Chlamydia spp., Claviceps spp., Clostridium spp., Cryptosporidium spp., Cyclospora spp., E. coli, Entamoeba spp., Fusarium spp., Gardnerella spp., Giardia spp., Gibberella spp., Helicobacter spp., Klebsiella spp., Listeria spp., Mycoplasma spp., Necator spp., Neisseria spp., Penicillium spp., Plesiomonas spp., Salmonella spp., Shigella spp., Staphylococcus spp., Streptococcus spp., Taenia spp., Trichomonas spp., Vibrio spp., Yersinia spp., Bacteroides spp., Peptostreptococcus, Lactobacillus spp., Enterobacterium and combinations thereof.

13. The method of claim 11 , wherein the pathogenic organism is selected from the group consisting of Aeromonas hydrophila, Ancylostoma caninum, Ancylostoma duodenale, Ascaris lumbricoides, Bacillus thuringiensis, Campylobacter jejuni, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Chlamydia trachomatis, Clostridium difficile, Clostridium perfringens , typical EPEC strains, atypical EPEC (aEPEC) strains, Helicobacter pylori, Listeria monocytogenes, Necator americanus, Neisseria gonorrhoeae, Plesiomonas shigelloides, Salmonella enterica serovar Typhi, Salmonella typhimurium, Salmonella enterica serovar Typhi, Shigella dysenteriae, Staphylococcus aureus, Taenia saginata, Taenia solium, Trichomonas vaginalis, Vibrio cholerae O1, Vibrio cholerae O139, Vibrio parahaemolyticus, Yersinia enterocolitica , and combinations thereof.

14. The method of claim 11 , wherein the pathogen-related toxin is selected from the group consisting of alpha toxin, Alternaria mycotoxin, Aspergillus mycotoxin, Bacillus thuringiensis delta endotoxin, Byssochlamys mycotoxin, Campylobacter jejuni enterotoxin, Cholera toxin, Claviceps mycotoxin, Clostridium perfringens enterotoxin, endotoxin from gram negative bacteria, E. coli heat stable enterotoxins LT and LT-II, Fusarium mycotoxin, Gibberella mycotoxin, Penicillium mycotoxin, perfringolysin 0 produced by Clostridium perfringens type C or type B, Shiga toxin, Staphylococcus enterotoxin B, and combinations thereof.

15. The method of claim 11 , wherein the pathogen-related toxin is selected from the group consisting of an enterotoxin, endotoxin, exotoxin, and combinations thereof.

16. The method of claim 11 , wherein the pathogen-related adhesion element is selected from the group consisting of E. coli K99 pili adherence factor, E. coli K88 pili adherence factor, E. coli 987P pili adherence factor, E. coli F41 pili adherence factor, E. coli F41 pili adherence factor, and combinations thereof.

17. The method of claim 11 , wherein the pathogen-related adhesion element is selected from the group consisting of one or more adhesins, cadherins, cilia, fimbrillae, viral adhesin structures, and combinations thereof.

18. The method of claim 1 , wherein the subject is treated and an expression of one or more biomarkers is decreased, wherein the one or more biomarkers are selected from the group consisting of fecal Reg IB, fecal MPO, serum sCD14, serum CRP, urine lactulose: mannitol (L:M) ratio, plasma IL-6, fecal IL-6, plasma TNF alpha, fecal TNF alpha, plasma IL-IRa, plasma IL-1sR1, and combinations thereof.

19. The method of claim 1 , wherein the method further comprises administering one or more of vitamin A, vitamin D, vitamin E, vitamin B12, vitamin B6, riboflavin, niacin, pantothenic acid, thiamine, choline, folic acid, biotin, vitamin K, vitamin C, cobalt, copper, iron, manganese, iodine, calcium, magnesium, phosphorus, a zinc supplement, and selenium.

20. The method of claim 1 , wherein the method further comprising administering one or more of about 100 pg to about 1000 pg vitamin A, about 15 mg to about 60 mg vitamin C, about 80 pg to about 600 pg folic acid, about 0.5 mg to about 18 mg iron, and zinc.

21. The method of claim 1 , wherein the subject is treated and one or more changes are induced, wherein the one or more changes are selected from the group consisting of decreased enteric inflammation, change in intestinal microbiome, decreased blunting of intestinal villi, increased intestinal integrity, decreased ulceration, decreased leakage of intestinal contents, decreased systemic inflammation, increased weight-for-age (WAZ) z-score, increased height-for-age (HA Z) z-score, increased weight-for-height z-score (WHZ), increased mid-upper arm circumference (MU AC), change in antigen-specific antibody titer in the subject, reduction of diarrhea volume, reduction of diarrhea duration, reduction of abdominal pain, reduction of nausea, reduction of abdominal cramping, reduction of loss of bowel control or urgency of diarrhea symptoms; increase in physician-assessed well-being of the subject, decreased abnormal flattening of villi and inflammation of the lining of small intestine, decreased presence of inflammatory cells, and combinations thereof.

22. The method of claim 1 , wherein a small intestinal bacterial overgrowth (SIBO) of the subject is measured using hydrogen breath testing.

23. The method of claim 22 , wherein the SIBO of the subject is >12 ppm greater than a baseline or control measurement of SIBO after lactulose of the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: GRABOWSKY, MARK
To: PANTHERYX, INC.
Reel/Frame 059569/0899 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: MARCHBANK, TANIA
To: PANTHERYX, INC.
Reel/Frame 060004/0579 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: KELLY, PAUL
To: PANTHERYX, INC.
Reel/Frame 060004/0867 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: CHOUDHRY, NAHEED
To: PANTHERYX, INC.
Reel/Frame 060005/0113 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: STARZL, TIMOTHY W.
To: PANTHERYX, INC.
Reel/Frame 060005/0167 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 12, 2022
From: PLAYFORD, RAYMOND J.
To: PANTHERYX, INC.
Reel/Frame 060019/0709 →
Continuity (5)
Provisional Application 62978104 · Feb 18, 2020
Provisional Application 62940133 · Nov 25, 2019
Provisional Application 62896429 · Sep 5, 2019
Provisional Application 62810637 · Feb 26, 2019
Related Publication 20220047646A1 · Feb 17, 2022
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