Methods of administering anti-fibrotic therapy

Patent metadata

Field	Value
Publication number	US-11207304-B2
Application number	US-201716465015-A
Country	US
Kind code	B2
Filing date	Nov 29, 2017
Priority date	Nov 30, 2016
Publication date	Dec 28, 2021
Grant date	Dec 28, 2021

Abstract

The present disclosure relates to methods of administering Compound I for treating fibrotic disorders, inflammatory disorders or autoimmune disorders.

First claim

What is claimed is:

1. A method for providing oral Compound I therapy to a subject:

comprising providing a therapeutically effective amount of Compound I to the subject; and
advising the subject not to take a gastric acid reducing agent concomitantly with Compound I.

2. The method of claim 1 , wherein the gastric acid reducing agent is selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), or an antacid, or combinations thereof.

3. The method of claim 2 , wherein the gastric acid reducing agent is a PPI.

4. The method of claim 3 , wherein the PPI is rabeprazole.

5. The method of claim 1 , further comprising advising the subject not to take the gastric acid reducing agent prior to or subsequent to taking the Compound I.

6. The method of claim 1 , further comprising advising the subject to take the Compound I with food.

7. The method of claim 1 , wherein the subject has an intra-gastric pH equal to or less than 4.

8. The method of claim 7 , wherein the subject has an intra-gastric pH less than 3.

9. The method of claim 1 , wherein the subject is in need of a gastric acid reducing agent.

10. The method of claim 1 , comprising providing a Compound I to the subject at a dosage in a range of 1 mg to 5000 mg per day.

11. A method for providing oral Compound I therapy to a subject:

comprising administering a therapeutically effective amount of Compound I to the subject and avoiding concomitant administration of a gastric acid reducing agent.

12. The method of claim 11 , wherein the gastric acid reducing agent is selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), or an antacid, or combinations thereof.

13. The method of claim 12 , wherein the gastric acid reducing agent is a PPI.

14. The method of claim 13 , wherein the PPI is rabeprazole.

15. The method of claim 11 , comprising administering the Compound I with food.

16. The method of claim 11 , wherein the subject has an intra-gastric pH equal to or less than 4.

17. The method of claim 16 , wherein the subject has an intra-gastric pH less than 3.

18. The method of claim 11 , wherein the subject is in need of a gastric acid reducing agent.

19. The method of claim 11 , comprising providing a Compound I to the subject at a dosage in a range of 1 mg to 5000 mg per day.

20. A method for providing Compound I therapy to a subject in need thereof and in need of a gastric acid reducing agent:

comprising administering Compound I to the subject at a dosage of:
(i) 200 mg BID;
(ii) 525 mg QD; or
(iii) 275 mg BID; and
avoiding co-administration of a gastric acid reducing agent selected from a proton pump inhibitor (PPI), a histamine 2 receptor antagonist (H2RA), an antacid, or combinations thereof.

Assignees

• Genentech Inc

Inventors

• Pan Lin
• Cheung Dorothy Sze-Wing
• Harris Jeffrey Mark
• Strombom Indiana

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61K31/437 Primary

  the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline · CPC title