Intestinal alkaline phosphatase-based treatments of metabolic disorders

Patent metadata

Field	Value
Publication number	US-2022257726-A1
Application number	US-202017626932-A
Country	US
Kind code	A1
Filing date	Jul 16, 2020
Priority date	Jul 18, 2019
Publication date	Aug 18, 2022
Grant date	—

Abstract

The present invention relates, inter alia, to combination therapies of specific commensal gastrointestinal bacteria with therapeutic intestinal alkaline phosphatases for the treatment of disease, such as metabolic disorders. The present invention further relates to compositions comprising the combination of specific commensal gastrointestinal bacteria with therapeutic alkaline phosphatases and use of the compositions in the treatment of metabolic disorders.

First claim

1 . A method of treating or preventing a metabolic disorder in a patient in need thereof, comprising administering to the patient an intestinal alkaline phosphatase (IAP), wherein the patient is undergoing therapy with a composition comprising at least one commensal gastrointestinal bacteria.

2 . The method of claim 1 , wherein the composition comprising at least one commensal gut bacteria is a fecal microbiota transplant comprising at least one commensal gut bacteria.

3 . The method of claim 1 , wherein the commensal gastrointestinal bacteria is Bacteroides acidifaciens.

4 . The method of any one of the preceding claims, wherein the fecal transplant is stool or a derivative thereof.

5 . The method of any one of the preceding claims, wherein the fecal transplant is derived from a human donor.

6 . The method of any one of the preceding claims, wherein the fecal transplant is administered via one or more of oral administration, colonoscopy, sigmoidoscopy, enema, naso-gastric intubation, naso-duodenal intubation, and naso-jejunal intubation.

7 . The method of claim 1 , wherein the composition comprising at least one commensal gastrointestinal bacteria is an isolated bacterial composition.

8 . The method of claim 7 , wherein the bacteria are isolated from one or more of human stool, the human GI tract, and the human gut.

9 . The method of claim 8 , wherein the isolated commensal gastrointestinal bacteria is grown in pure or mixed cultures.

10 . The method of any one of claims 7 - 9 , wherein the isolated commensal gastrointestinal bacteria is formulated as one or more of tablets, pills, powders, capsules, lyophilized compositions, and aqueous formulations.

11 . The method of any one of the preceding claims, wherein the IAP is administered orally.

12 . The method of claim 7 , wherein the composition comprising isolated commensal gastrointestinal bacteria is administered orally.

13 . The method of claim 3 , wherein the IAP is bovine IAP (bIAP).

14 . The method of any one of the preceding claims, wherein the method increases or preserves the number of commensal bacteria and/or composition of the gastrointestinal microbiome of the patient.

15 . The method of any one of the preceding claims, wherein the method inhibits the growth of or decreases the number of pathogenic bacteria in the gastrointestinal microbiome of the patient.

16 . The method of any one of the preceding claims, wherein the metabolic disorder is obesity.

17 . The method of any one of the preceding claims, wherein the metabolic disorder is type 1 or type 2 diabetes.

18 . The method of any one of the preceding claims, wherein the metabolic disorder is a metabolic syndrome.

19 . The method of any one of the preceding claims, wherein the treatment of the metabolic disorder comprises amelioration of metabolic syndrome, weight loss, modulation of insulin, prevention of diabetes, modulation of energy metabolism, or prevention of obesity.

20 . A method of treating or preventing a metabolic disorder in a patient in need thereof, comprising administering to the patient a composition comprising at least one commensal gastrointestinal bacteria, wherein the patient is undergoing therapy with an intestinal alkaline phosphatase (IAP).

21 . The method of claim 20 , wherein the composition comprising at least one commensal gastrointestinal bacteria is a fecal microbiota transplant comprising at least one commensal gastrointestinal bacteria.

22 . The method of either claim 20 or 21 , wherein the commensal gastrointestinal bacteria is Bacteroides acidifaciens.

23 . The method of claims 20 - 22 , wherein the fecal transplant is stool or a derivative thereof.

24 . The method of any one of claims 20 - 23 , wherein the fecal transplant is derived from a human donor.

25 . The method of any one of claims 20 - 24 , wherein the fecal transplant is administered via one or more of oral administration, colonoscopy, sigmoidoscopy, enema, naso-gastric intubation, naso-duodenal intubation, and naso-jejunal intubation.

26 . The method of claim 20 , wherein the composition comprising at least one commensal gastrointestinal bacteria is an isolated bacterial composition.

27 . The method of claim 26 , wherein the commensal gastrointestinal bacteria are isolated from one or more of human stool, the human GI tract, and the human gut.

28 . The method of any one of claims 26 - 27 , wherein the isolated commensal gastrointestinal bacteria is grown on pure or mixed cultures.

29 . The method of any one of claims 26 - 28 , wherein the isolated commensal gastrointestinal bacteria is formulated as one or more of tablets, pills, powders, capsules, lyophilized compositions, and aqueous formulations.

30 . The method of any one of claims 22 - 29 wherein the IAP is administered orally.

31 . The method of any one of claims 22 - 30 , wherein the composition comprising isolated commensal gastrointestinal bacteria is administered orally.

32 . The method of claim 20 , wherein the IAP is bovine IAP (bIAP).

33 . The method of any one of claims 20 - 32 , wherein the method increases or preserves the number of commensal bacteria and/or composition of the gastrointestinal microbiome of the patient.

34 . The method of any one of claims 20 - 33 , wherein the method inhibits the growth of or decreases the number of pathogenic bacteria in the gastrointestinal microbiome of the patient.

35 . The method of any one of claims 20 - 34 , wherein the metabolic disorder is obesity.

36 . The method of any one of claims 20 - 34 , wherein the metabolic disorder is type 1 or type 2 diabetes.

37 . The method of any one of claims 20 - 34 , wherein the metabolic disorder is a metabolic syndrome.

38 . The method of any one of claims 20 - 37 , wherein the treatment of the metabolic disorder comprises amelioration of metabolic syndrome, weight loss, modulation of insulin, prevention of diabetes, modulation of energy metabolism, or prevention of obesity.

39 . A method of treating or preventing a metabolic disorder in a patient in need thereof, comprising administering to the patient a co-formulation of a composition comprising at least one commensal gastrointestinal bacteria and an intestinal alkaline phosphatase (IAP).

40 . The method of claim 39 , wherein the composition comprising at least one commensal gastrointestinal bacteria is a fecal microbiota transplant comprising at least one commensal gastrointestinal bacteria.

41 . The method of either claim 39 or 40 , wherein the commensal gastrointestinal bacteria is Bacteroides acidifaciens.

42 . The method of any one of claims 39 - 41 , wherein the fecal transplant is stool or a derivative thereof.

43 . The method of any one of claims 39 - 42 , wherein the fecal transplant is derived from a human donor.

44 . The method of any one of claims 39 - 43 , wherein the fecal transplant is administered via one or more of oral administration, colonoscopy, sigmoidoscopy, enema, naso-gastric intubation, naso-duodenal intubation, and naso-jejunal intubation.

Assignees

• Synthetic Biologics Inc

Inventors

• Furlan Freguia Christian

Classifications

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P3/04

  Anorexiants; Antiobesity agents · CPC title

• C12Y301/03001

  Alkaline phosphatase (3.1.3.1) · CPC title

• C12N9/16

  acting on ester bonds (3.1) · CPC title

• A61K35/24

  Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid (saliva A61K35/38) · CPC title