Compositions and methods for treating inflammatory bowel disease using CCR9 inhibitor and anti-TNF-alpha blocking antibodies
Provided herein are compositions, methods and kits for treating inflammatory bowel disease (IBD) such as Crohn's disease and ulcerative colitis in a mammal in need thereof. The method include administering to a subject with IBD a combination therapy containing a therapeutically effective amount of a chemokine receptor 9 (CCR9) inhibitor compound and a therapeutically effective amount of an anti-TNFα antibody. Also provided herein is a kit containing the CCR9 inhibitor compound and anti-TNFα antibody.
1. A method of treating or reducing the development of inflammatory bowel disease in a mammal, said method comprising administering a suitable amount of a CCR9 inhibitor with an anti-TNFα blocking antibody, wherein the CCR9 inhibitor is Compound 1
2. The method of claim 1 , wherein the inflammatory bowel disease is Crohn's disease (CD) or ulcerative colitis (UC).
3. The method of claim 1 , wherein the anti-TNFα blocking antibody is infliximab, adalimumab, golimumab, certolizumab pegol, or a biosimilar, biobetter, or bioequivalent thereof.
4. The method of claim 1 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are administered in a combination formulation.
5. The method of claim 1 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are administered sequentially.
6. The method of claim 5 , wherein the CCR9 inhibitor is administered prior to the anti-TNFα blocking antibody.
7. The method of claim 5 , wherein the CCR9 inhibitor is administered after administration of the anti-TNFα blocking antibody.
8. The method of claim 1 , wherein the anti-TNFα blocking antibody is infliximab, or a biosimilar, biobetter, or bioequivalent thereof.
9. The method of claim 1 , wherein the anti-TNFα blocking antibody is adalimumab, or a biosimilar, biobetter, or bioequivalent thereof.
10. The method of claim 1 , wherein the anti-TNFα blocking antibody is golimumab, or a biosimilar, biobetter, or bioequivalent thereof.
11. The method of claim 1 , wherein the anti-TNFα blocking antibody is certolizumab pegol, or a biosimilar, biobetter, or bioequivalent thereof.
12. A composition for treating or reducing the development of inflammatory bowel disease in a mammal, said composition comprising a therapeutically effective amount of a CCR9 inhibitor, a therapeutically effective amount of an anti-TNFα blocking antibody, and a pharmaceutically acceptable carrier or excipient, wherein the CCR9 inhibitor is Compound 1
13. The composition of claim 12 , wherein the anti-TNFα blocking antibody is infliximab, adalimumab, golimumab, or a biosimilar, biobetter, or bioequivalent thereof.
14. A kit for treating or reducing the development of inflammatory bowel disease in a mammal, said kit comprising a therapeutically effective amount of a CCR9 inhibitor, and a therapeutically effective amount of an anti-TNFα blocking antibody, with instructions for effective administration, wherein the CCR9 inhibitor is Compound 1
15. The kit of claim 14 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are formulated for sequential administration.
16. The kit of claim 14 , wherein the CCR9 inhibitor and the anti-TNFα blocking antibody are formulated for concomitant administration.