Treatment of a disease of the gastrointestinal tract with IL-10 or an IL-10 agonist

1. A method of treating ulcerative colitis in a subject, the method comprising: orally administering to the subject an ingestible device comprising: an ingestible housing comprising a reservoir, the reservoir containing a pharmaceutical formulation comprising a therapeutically effective amount of an IL-10 receptor agonist selected from the group consisting of recombinant human IL-10, pegylated IL-10, viral IL-10, IL-10 fusion protein, IL-10 antibody or antigen-binding fragment thereof, and IL-10 peptide mimetic; a release mechanism having a closed state wherein the pharmaceutical formulation is retained in the reservoir and an open state which allows for the release of the pharmaceutical formulation from the reservoir to the exterior of the ingestible device; an actuator which controls the transition of the release mechanism from the closed state to the open state; a light source configured to produce light that interacts with a gastrointestinal (GI) tract of the subject to provide light reflectance; a detector configured to detect the light reflectance to detect the GI tract; and a processor coupled to the detector and to the actuator, wherein the processor triggers the actuator to cause the release mechanism to transition from the closed state to the open state when the ingestible device is located in the cecum based on the detected light reflectance, wherein the cecum has been predetermined to be proximal to one or more disease sites, thereby releasing the pharmaceutical formulation comprising the IL-10 receptor agonist from the ingestible device when the ingestible device is located in the cecum of the subject.

2. The method of claim 1 , wherein the one or more disease sites is in the colon.

3. The method of claim 1 , wherein the IL-10 receptor agonist is an antibody or an antigen-binding antibody fragment.

4. The method of claim 1 , wherein the IL-10 receptor agonist is a recombinant IL-10 or a pegylated recombinant IL-10.

5. The method of claim 4 , wherein the IL-10 receptor agonist is a pegylated recombinant human IL-10.

6. The method of claim 1 , wherein the ingestible device further comprises one or more machine-readable hardware storage devices that stores instructions that are executable by the processor to determine that the ingestible device is in the cecum of the subject to an accuracy of at least 70%.

7. The method of claim 1 , wherein the method further comprises determining the location of the ingestible device in the cecum of the subject to an accuracy of at least 85%.

8. The method of claim 1 , wherein the ingestible device is configured to detect light reflectance from an environment external to the housing.

9. The method of claim 8 , wherein the detected reflectance indicates that the ingestible device is located in the cecum of the subject.

10. The method of claim 9 , wherein the detected reflectance autonomously triggers the release of the pharmaceutical formulation comprising the IL-10 receptor agonist from the ingestible device.

11. The method of claim 8 , wherein the detected reflectance comprises light of at least two different wavelengths.

12. The method of claim 8 , wherein determining the location of the ingestible device in the cecum comprises detecting a transition of the ingestible device from the ileum to the cecum.

13. The method of claim 12 , wherein detecting the transition of the ingestible device from the ileum to the cecum comprises detecting a change in the ratio of reflected red light to reflected green light.

14. The method of claim 13 , wherein detecting the transition of the ingestible device from the ileum to the cecum further comprises detecting a change in the ratio of reflected green light to reflected blue light.

15. The method of claim 1 , wherein the ingestible device comprises a gas generating cell located within the housing, wherein the gas generating cell is capable of generating a gas; and the ingestible device is configured so that, when the gas generating cell generates the gas, the gas creates an internal pressure that forces a release mechanism from a closed state, which retains the IL-10 receptor agonist in the reservoir, to an open state, thereby allowing for the release of the IL-10 receptor agonist from the reservoir to the exterior of the device.

16. The method of claim 15 , wherein the reservoir is configured to friction fit with the ingestible device.

17. The method of claim 15 , wherein the reservoir is configured to attach to the housing of the ingestible device.

18. The method of claim 15 , wherein the ingestible device comprises a safety device placed within or attached to the housing, wherein the safety device is configured to relieve the internal pressure within the housing when the internal pressure exceeds a threshold level.

19. The method of claim 1 , further comprising releasing the pharmaceutical formulation comprising the IL-10 receptor agonist to the cecum as a bolus.

20. The method of claim 1 , further comprising determining the level of the IL-10 receptor agonist in the plasma of the subject following the oral administration of the ingestible device, wherein the level of the IL-10 receptor agonist is lower than the level of the IL-10 receptor agonist in the plasma of a subject at substantially the same time point following systemic administration of an equal amount of the IL-10 receptor agonist.

21. The method of claim 1 , wherein releasing the IL-10 receptor agonist from the ingestible device is not dependent on pH, enzymatic activity or bacterial activity at or in the vicinity of the predetermined location.

22. The method of claim 4 , wherein the IL-10 receptor agonist is a recombinant human IL-10.

23. The method of claim 1 , wherein the IL-10 receptor agonist is a fusion protein.

24. The method of claim 23 , wherein the fusion protein comprises an IL-10 protein, or a functional fragment thereof, and a fusion partner that targets the IL-10 receptor agonist to inflamed tissue.

25. The method of claim 24 , wherein the fusion partner is an antibody or antigen-binding antibody fragment.

26. The method of claim 24 , wherein the inflamed tissue is inflamed gastrointestinal tissue.

27. The method of claim 23 , wherein the fusion protein comprises recombinant human IL-10.