Therapies for preventing or suppressing
View Patent ↗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.
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.