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EP-4735022-A1 - COMPOSITION COMPRISING LACTOPEROXIDASE AND AN IODIDE SALT, AND USE THEREOF FOR THE TREATMENT OF EQUINE GASTRIC ULCER SYNDROME

EP4735022A1EP 4735022 A1EP4735022 A1EP 4735022A1EP-4735022-A1

Abstract

Compositions comprising lactoperoxidase and one or more iodide salts for treating equine gastric ulcer syndrome.

Inventors

  • O'BRIAIN, Killian

Assignees

  • O'Briain, Killian

Dates

Publication Date
20260506
Application Date
20240918

Claims (20)

  1. 1 . A composition, such as a pharmaceutical composition, comprising: lactoperoxidase, an iodide salt, and a pharmaceutically acceptable carrier and/or excipient, for use in the treatment or prevention of equine gastric ulcer syndrome, optionally wherein the equine gastric ulcer syndrome comprises equine squamous gastric disease and/or equine glandular gastric disease.
  2. 2. The composition for use of claim 1 , wherein the lactoperoxidase and iodide salt are in a weight ratio of from 1 :10 to 10:1 , preferably, from 1 :3 to 3:1 , most preferably from 1 :1.3 to 1 .3:1 , such as about 1 :1 .
  3. 3. The composition for use of any preceding claim, wherein the iodide salt is selected from sodium iodide, potassium iodide, lithium iodide, ammonium iodide, calcium iodide, caesium iodide, hydrogen iodide, rhodium iodide and combinations thereof, preferably the iodide salt is sodium iodide and/or potassium iodide, more preferably the iodide salt is potassium iodide.
  4. 4. The composition for use of any preceding claim, wherein the treatment comprises administration of at least 0.24 mmol of the iodide salt, and at least 40 mg of the lactoperoxiase on a daily basis, preferably, wherein the treatment comprises administration of at least 0.36 mmol of the iodide salt and at least 60 mg of the lactoperoxidase on a daily basis, more preferably, wherein the treatment comprises administration of at least 0.48 mmol of the iodide salt and at least 80 mg of the lactoperoxidase on a daily basis.
  5. 5. The composition for use of any preceding claim, wherein the treatment comprises administration of from 0.24 mmol to 1.2 mmol of the iodide salt, and 40 mg to 200 mg of the lactoperoxidase to the equid on a daily basis.
  6. 6. The composition for use of any preceding claim, wherein the treatment comprises administration of from 0.36 mmol to 1.2 mmol of the iodide salt and from 60 mg to 200 mg of the lactoperoxidase to the equid on a daily basis.
  7. 7. The composition for use of any preceding claim, wherein the treatment comprises administration of from 0.48 mmol to 0.60 mmol of the iodide salt and from 80 to 100 mg of the lactoperoxidase on a daily basis.
  8. 8. The composition for use according to any preceding claim, wherein the treatment comprises administration of at least 40 mg of the iodide salt, and at least 40 mg of the lactoperoxidase on a daily basis, preferably wherein the treatment comprises administration of at least 60 mg of the iodide salt and at least 60 mg of the lactoperoxidase on a daily basis, more preferably, wherein the treatment comprises administration of at least 80 mg of the iodide salt and at least 80 mg of the lactoperoxidase on a daily basis.
  9. 9. The composition for use of any preceding claim, wherein the composition is formulated as one or more oral dosage forms.
  10. 10. The composition for use of any preceding claim, wherein the treatment comprises administration of one or more unit doses of the composition.
  11. 11. The composition for use of claim 10, wherein a unit dose of the composition comprises from 5 mg to 50 mg lactoperoxidase, and wherein the unit dose of the composition comprises 0.030 mmol to 0.30 mmol iodide salt.
  12. 12. The composition for use of claim 11 , wherein a unit dose of the composition comprises from 8 mg to 20 mg lactoperoxidase, and wherein the unit dose of the composition comprises from 0.048 mmol to 0.12 mmol iodide salt.
  13. 13. The composition for use of any preceding claim, wherein a unit dose of the composition comprises lactoperoxidase present in an amount of from about 8 mg to about 20 mg, and in an amount of from about 0.5 wt% to about 5 wt% based on the total weight of the unit dose, and wherein the iodide salt is potassium iodide, and is present in an amount of from about 8 mg to about 20 mg, and in an amount of from about 0.5 wt% to about 5 wt% based on the total weight of the unit dose.
  14. 14. The composition for use of any preceding claim, wherein said composition further comprises vitamin C, and optionally comprises zinc oxide.
  15. 15. The composition for use of any preceding claim, wherein the equid is a horse or a pony.
  16. 16. A combination for use in the treatment of equine gastric ulcer syndrome such as equine squamous gastric disease and/or equine glandular gastric disease, the combination comprising: a lactoperoxidase; and an iodide salt; wherein the lactoperoxidase and iodide salt are administered sequentially or simultaneously to an equid, such as a horse or pony, optionally, in a relative weight ratio of from 1 :10 to 10:1 , preferably, in a relative weight ratio of from about 1 :2 to 2:1 , more preferably in a relative weight ratio of from about 1 :1 .3 to 1 .3:1 .
  17. 17. The combination for use of claim 16, wherein the treatment comprises administration of at least 0.24 mmol of the iodide salt, and at least 40 mg of the lactoperoxidase to the equid on a daily basis, preferably, the treatment comprises administration of at least 0.36 mmol of the iodide salt and at least 60 mg of the lactoperoxidase to the equid on a daily basis, more preferably, the treatment comprises administration of at least 0.48 mmol of the iodide salt and at least 80 mg of the lactoperoxidase to the equid on a daily basis.
  18. 18. The combination for use of claim 16 or 17, wherein the treatment comprises administration of 0.24 mmol to 1.2 mmol of the iodide salt, and 40 mg to 200 mg of the lactoperoxidase to the equid on a daily basis.
  19. 19. The combination for use of claim 16 or 17, wherein the treatment comprises administration of 0.36 mmol to 1.2 mmol of the iodide salt, and 60 mg to 200 mg of the lactoperoxidase to the equid on a daily basis.
  20. 20. The combination for use of any one of claims 16 to 19, wherein the wherein the equine gastric ulcer syndrome is equine squamous gastric disease.

Description

COMPOSITION COMPRISING LACTO PEROXIDASE AND AN IODIDE SALT, AND USE THEREOF FOR THE TREATMENT OF EQUINE GASTRIC ULCER SYNDROME Field [0001] The present invention is concerned with a pharmaceutical composition for use in treating or preventing equine gastric ulcer syndrome. In particular, the present invention is concerned with a pharmaceutical composition for use in treating equine squamous gastric disease and/or equine glandular gastric disease. Also provided is a feed additive or dietary supplement composition which is useful for treating, including prophylactically treating, equine gastric ulcer syndrome, such as equine squamous gastric disease and/or equine glandular gastric disease. [0002] The present invention is also concerned with pharmaceutical compositions for use in treating gastrointestinal bacterial infections in a mammal. The composition is particularly effective for treating bacterial infections in mammals, such as lambs, calves, humans, pigs and horses. Suitably, the mammals may be monogastric mammals. Also provided is a feed additive or dietary supplement composition which is useful for treating, including prophylactically treating, gastrointestinal bacterial infections in animals. [0003] The invention further provides animal feed comprising the feed additive or dietary supplement composition disclosed herein. The compositions disclosed are useful for ameliorating gastrointestinal bacterial infections without requiring antibiotics. [0004] In addition, the compositions of the present invention are useful for treating stomach ulcers, particularly in horses, cats and dogs. Background [0005] Equine gastric ulcer syndrome (EGUS) describes the development of ulcers on the inner wall of the stomach of a horse. Ulcers can vary in severity from a minor inflammation of the stomach lining through to severe ulceration and bleeding, with perforation of the stomach potentially leading to colic and sudden death. [0006] The stomach of the horse is comprised of two distinct regions, the squamous and glandular mucosa, separated by the margo plicatus. The glandular mucosa lines the ventral portion of the stomach and consists of gastric glands that secrete hydrochloric acid, pepsinogen, histamine, mucous, and sodium bicarbonate. The dorsal portion of the stomach is covered by squamous epithelium. The glandular mucosa lines approximately the lower two thirds of the stomach, whereas the squamous mucosa lines the upper third of the stomach. Ulceration of the stomach has been divided based upon ulcer/lesion location: equine glandular gastric disease (EGGD) refers to disease of the glandular portion of the stomach, and equine squamous gastric disease (ESGD) refers to disease of the squamous portion of the stomach. Equine gastric ulcer syndrome (EGUS) refers to disease of any portion of the stomach and is the umbrella term used. [0007] Gastric ulcers are sores which form on the lining of the stomach. These are extremely prevalent in horses with an estimated 50-90% of horses suffering from ulceration. EGUS can be a major cause of poor athletic performance in racehorses, where prevalence of ulcers is very high. Ulcers occur from a variety of sources: racehorses are typically fed grain-rich diets, with lengthy fasting periods between meals when exercise is carried out; exercise has been shown to increase gastric acid production and decreases blood flow to the Gl tract, this coupled with reduced saliva production and indoor confinement are thought to lead to the contribution of stomach ulcers. Increased levels of gastric ulcers are associated with an increased risk of colic. [0008] As outlined above. EGUS is highly prevalent particularly in high performance horses, and increases significantly in horses that are in training. EGUS is considered to result from disequilibrium between mucosal aggressive factors such as hydrochloric acid, pepsin, bile acids and organic acids, and mucosal protective factors such as mucus and bicarbonate. [0009] Current therapeutic strategies follow the mantra “no acid, no ulcer” and focus on neutralising existing gastric acid or blocking new gastric acid secretion to increase stomach pH. Suppression of gastric acid production can be achieved by using proton pump inhibitors such as rabeprazole, lansoprazole, dexlansoprazole, tenatoprazole, omeprazole and esomeprazole. [0010] EGUS can be treated by protecting the damaged gastric mucosa with mucosal protectants such as sucralfate (which is given orally) and misoprostol (which is given by injection), by neutralising gastric acid with antacids such as magnesium hydroxide, or by suppressing acid production by the oral use of proton pump inhibitors (PPI) or histamine type 2 (H2) receptor antagonists such as ranitidine. [0011] There are several drawbacks with such treatments. Mucosal protectants must be continuously present and available at all sites of ulceration to allow ulcers to heal. This requires high doses of the mucosal protectant and freque