IP Library Granted Patent US 8,921,529
Granted Patent B2
US 8,921,529 · App. 13/513,555 · Granted Dec 30, 2014

Therapies for preventing or suppressing

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Quick Facts
Patent No.
US 8,921,529
App. No.
13/513,555
Granted
Dec 30, 2014
Kind
B2
Abstract

The present invention provides an antibody composition comprising ovine antibodies, for use in the prevention or treatment of C. difficile infection wherein the antibodies bind to a C. difficile toxin, and wherein said prevention or treatment is by oral delivery of the antibody composition. Also provided is a pharmaceutical composition of ovine antibodies for oral delivery, which further comprises one or more means for protecting the antibodies from trypsin and/or chymotrypsin and/or stomach acid.

Claims (34)

1. A method for treatment of C. difficile infection, comprising orally administering an antibody composition, the antibody composition comprising ovine antibodies that bind to a C. difficile toxin,

wherein the antibodies bind to C. difficile Toxin A and to C. difficile Toxin B.

2. The method of claim 1 , wherein the antibodies are polyclonal antibodies.

3. The method of claim 1 , wherein the antibodies bind to C. difficile toxins Toxin A, Toxin B, and Binary Toxin.

4. The method of claim 1 , wherein the C. difficile Toxin A is selected from the group consisting of: Toxinotype 0, Toxinotype III and Toxinotype V.

5. The method of claim 1 , wherein the C. difficile Toxin B is selected from the group consisting of: Toxinotype 0, Toxinotype III, Toxinotype V, and Toxinotype VIII.

6. The method of claim 1 , wherein the antibody composition comprises:

the ovine antibodies that bind to a C. difficile toxin, and

at least one means for protecting said antibody composition from trypsin and/or chymotrypsin and/or stomach acid.

7. The method of claim 6 , wherein the at least one means for protecting said antibody composition from trypsin and/or chymotrypsin and/or stomach acid is selected from the group consisting of:

(a) a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin;

(b) an antibody that binds to trypsin and/or chymotrypsin and suppresses or inactivates the protease activity of said trypsin and/or chymotrypsin;

(c) a delivery vehicle selected from a liposome, a microsome, a nanosome, a pellet, a granular matrix, a bead, a microsphere, a nanoparticle formulation, or an aqueous solution;

(d) an antacid molecule;

(e) a PEGylation moiety covalent attached to one of more of the antibodies.

8. The method of claim 7 , wherein the antibody composition includes the antacid molecule and:

(a) the polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin; or

(b) the antibody that binds to trypsin and/or chymotrypsin and inactivates the protease activity of said trypsin and/or chymotrypsin.

9. The method according to claim 1 , further comprising administering at least one trypsin and/or chymotrypsin inhibitor and/or antacid prior to, simultaneously with, or subsequent to the administering the antibody composition.

10. The method according to claim 1 , further comprising non-orally administering a second ovine antibody composition wherein said second ovine antibody composition comprises ovine antibodies that bind to a C. difficile toxin.

11. The method according to claim 1 , wherein a subject to be treated is a subject selected from the group consisting of: hospitalized subjects; subjects over 65 years old; subjects receiving broad-range spectrum antibiotics; subjects having previous CDI infection; subjects having close proximity to symptomatic CDI patients; subjects having mild to moderate disease severity; subjects presenting as asymptomatic but considered at high risk of relapse; and subjects having close proximity to CDI outbreak areas or patients.

12. The method of claim 1 , wherein the antibody composition comprises:

the ovine antibodies that bind to a C. difficile toxin, and

an excipient,

wherein the excipient provides for colonic delivery of the antibodies from oral administration.

13. The method of claim 12 , wherein the excipient is selected from the group consisting of:

(a) a polypeptide which binds specifically to and suppresses or inactivates the proteolytic activity of trypsin and/or chymotrypsin;

(b) an antibody that binds to trypsin and/or chymotrypsin and suppresses or inactivates the protease activity of trypsin and/or chymotrypsin;

(c) a delivery vehicle selected from a liposome, a microsome, and a nanosome; and

(d) an antacid molecule.

14. A method for preventing at least one clinical symptom of C. difficile infection, comprising orally administering an antibody composition, the antibody composition comprising ovine antibodies that bind to a C. difficile toxin,

wherein the antibodies bind to C. difficile Toxin A and to C. difficile Toxin B.

15. The method according to claim 14 , further comprising administering at least one trypsin and/or chymotrypsin inhibitor and/or antacid prior to, simultaneously with, or subsequent to the administering of the antibody composition.

16. The method according to claim 14 , further comprising non-orally administering a second ovine antibody composition wherein said second ovine antibody composition comprises ovine antibodies that bind to a C. difficile toxin.

Assignments (4)
NUNC PRO TUNC ASSIGNMENT Recorded Sep 19, 2019
From: THE SECRETARY OF STATE FOR HEALTH
To: SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE
Reel/Frame 052144/0237 →
PROPERTY TRANSFER SCHEME Recorded Jul 2, 2013
From: HEALTH PROTECTION AGENCY
To: THE SECRETARY OF STATE FOR HEALTH
Reel/Frame 030739/0950 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2012
From: SHONE, CLIFFORD; ROBERTS, APRIL
To: HEALTH PROTECTION AGENCY
Reel/Frame 028929/0549 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2012
From: LANDON, JOHN
To: MICROPHARM LIMITED
Reel/Frame 028929/0621 →