IP Library Granted Patent US 10,980,739
Granted Patent B2
US 10,980,739 · App. 16/465,803 · Granted Apr 20, 2021

Treatment of a disease of the gastrointestinal tract with a chemokine/chemokine receptor inhibitor

Inventors: Mitchell Lawrence Jones (La Jolla, CA); Christopher Loren Wahl (San Diego, CA); Sharat Singh (Rancho Santa Fe, CA); Harry Stylli (La Jolla, CA); Allison Luo (Basking Ridge, NJ)
Assignee: Progenity, Inc.
A61K9/0009A61K9/0053A61K31/4425A61K31/495A61K39/3955
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Quick Facts
Patent No.
US 10,980,739
App. No.
16/465,803
Granted
Apr 20, 2021
Kind
B2
Abstract

This disclosure features methods and compositions for treating diseases of the gastrointestinal tract with a chemokine/chemokine receptor inhibitor.

Claims (25)

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 a chemokine/chemokine receptor inhibitor;

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 the subject's gastrointestinal (GI) tract 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 chemokine/chemokine receptor inhibitor from the ingestible device when the ingestible device is located in the cecum of the subject,

wherein the chemokine/chemokine receptor inhibitor is a monoclonal antibody selected from the group consisting of eldelumab, BMS-986184, LY-3041658, NI-0801, GSK3050002, and E-6011.

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 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%.

4. 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%.

5. The method of claim 1 , wherein the detected reflectance autonomously triggers the release of the pharmaceutical formulation comprising the chemokine/chemokine receptor inhibitor from the ingestible device.

6. The method of claim 1 , wherein the detected reflectance comprises light of at least two different wavelengths.

7. The method of claim 1 , 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.

8. The method of claim 7 , 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.

9. The method of claim 8 , 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.

10. 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 chemokine/chemokine receptor inhibitor in the reservoir, to an open state, thereby allowing for the release of the chemokine/chemokine receptor inhibitor from the reservoir to the exterior of the device.

11. The method of claim 10 , wherein the reservoir is configured to friction fit with the ingestible device.

12. The method of claim 10 , wherein the reservoir is configured to attach to the housing of the ingestible device.

13. The method of claim 10 , 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.

14. The method of claim 1 , further comprising releasing the pharmaceutical formulation comprising the chemokine/chemokine receptor inhibitor to the cecum as a bolus.

15. The method of claim 1 , further comprising determining the level of chemokine/chemokine receptor inhibitor in the plasma of the subject following the oral administration of the ingestible device, wherein the level of chemokine/chemokine receptor inhibitor is lower than the level of the chemokine/chemokine receptor inhibitor in the plasma of a subject at substantially the same time point following systemic administration of an equal amount of the chemokine/chemokine receptor inhibitor.

16. The method of claim 1 , wherein releasing the chemokine/chemokine receptor inhibitor from the ingestible device is not dependent on pH, enzymatic activity or bacterial activity at or in the vicinity of the predetermined location.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2025
From: BIORA THERAPEUTICS, INC.
To: BT BIDCO, INC.
Reel/Frame 070585/0061 →
LIEN Recorded Mar 18, 2025
From: BIORA THERAPEUTICS, INC.
To: BT BIDCO LLC
Reel/Frame 070552/0366 →
SECURITY INTEREST Recorded Dec 21, 2023
From: BIORA THERAPEUTICS, INC.
To: GLAS TRUST COMPANY LLC, AS COLLATERAL AGENT
Reel/Frame 066089/0235 →
CHANGE OF NAME Recorded Apr 28, 2022
From: PROGENITY, INC.
To: BIORA THERAPEUTICS, INC.
Reel/Frame 059820/0076 →
Continuity (5)
Provisional Application 62583929 · Nov 9, 2017
Provisional Application 62545129 · Aug 14, 2017
Provisional Application 62478744 · Mar 30, 2017
Provisional Application 62434369 · Dec 14, 2016
Related Publication 20200170937A1 · Jun 4, 2020