IP Library Granted Patent US 10,813,946
Granted Patent B2
US 10,813,946 · App. 14/048,983 · Granted Oct 27, 2020

Potassium binding polymers for treating hypertension and hyperkalemia

Inventors: Gerrit Klaerner (Los Gatos, CA); Lance Berman (San Francisco, CA)
Assignee: Vifor (International) Ltd.
A61K31/78A61K9/14A61K31/7004A61K33/06A61K33/24B01J39/20
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Quick Facts
Patent No.
US 10,813,946
App. No.
14/048,983
Granted
Oct 27, 2020
Kind
B2
Abstract

The present invention generally relates to methods of treating hypertension (HTN) in patients in need thereof wherein the patient optionally further suffers from chronic kidney disease (CKD) or Type II diabetes mellitus (T2DM). The invention also relates to methods of treating hyperkalemia in a patient in need thereof, wherein the patient suffers from CKD, T2DM or HTN and are optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The invention also relates to methods of treating kidney disease in a patient in need thereof, wherein the patient is optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The methods can comprise administering an effective amount of a potassium-binding polymer to the patient to lower the patient's blood pressure and/or increase or stabilize the patient's kidney function.

Claims (21)

1. A method of treating hypertension in a patient, the method comprising (i) identifying a patient suffering from hypertension; and (ii) administering an effective amount of 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form to the patient daily for more than 8 weeks.

2. The method of claim 1 wherein the 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form is administered chronically.

3. The method of claim 1 wherein the patient's systolic blood pressure is reduced by 5 mm Hg or more after 4 weeks of treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form as compared to the patient's systolic blood pressure before treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

4. The method of claim 1 wherein the patient's systolic blood pressure is reduced by 9 mm Hg or more after 4 weeks of treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form as compared to the patient's systolic blood pressure before treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

5. The method of claim 1 wherein the patient had a systolic blood pressure of from 130 mmHg to 200 mm Hg before treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

6. The method of claim 1 wherein the patient had a systolic blood pressure of from 140 mmHg to 200 mm Hg before treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

7. The method of claim 1 wherein the patient had a systolic blood pressure of from 145 mmHg to 180 mmHg before treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

8. The method of claim 2 wherein the systolic blood pressure of the patient is maintained below 130 mm Hg over at least 90% of the period of treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

9. The method claim 2 wherein the diastolic blood pressure of the patient is maintained at below 80 mm Hg over at least 90% of the period of treatment with 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form.

10. The method of claim 1 wherein the patient is not being treated with an aldosterone antagonist.

11. The method of claim 1 wherein the patient does not have another condition that causes hypertension.

12. The method of claim 11 wherein the patient does not have Type 2 diabetes.

13. The method of claim 11 wherein the patient does not have Class II or Class III heart failure (HF).

14. The method of claim 1 wherein the patient is not being treated with a heart failure therapy.

15. The method of claim 14 wherein the heart failure therapy is an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB), a beta blocker (BB), or a combination thereof.

16. The method of claim 1 wherein the patient is not being treated with an antihypertensive agent comprising a diuretic, a calcium channel blocker, an alpha blocker, a nervous system inhibitor, a vasodilator, an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB), a beta blocker (BB), or a combination thereof.

17. The method of claim 1 wherein the patient is normokalemic.

18. A method of treating hypertension in a chronic kidney disease patient in need thereof, a heart failure patient in need thereof, or a type 2 diabetes mellitus patient in need thereof, the patient optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent, the method comprising administering an effective amount of 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form to the patient daily for more than 8 weeks.

19. The method of claim 2 wherein the 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form is administered to the patient daily for more than 12 weeks.

20. The method of claim 18 wherein the 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer crosslinked in the salt or acid form is administered to the patient daily for more than 12 weeks.

21. The method of claim 1 , wherein the patient suffering from hypertension has a systolic blood pressure greater than 130 mmHg.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2019
From: RELYPSA, INC.
To: VIFOR (INTERNATIONAL) LTD.
Reel/Frame 049899/0058 →
RELEASE OF SECURITY INTEREST Recorded Sep 2, 2016
From: CANTOR FITZGERALD SECURITIES
To: RELYPSA, INC.
Reel/Frame 039621/0142 →
SECURITY INTEREST Recorded Apr 27, 2016
From: RELYPSA, INC.
To: CANTOR FITZGERALD SECURITIES
Reel/Frame 038394/0034 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 9, 2014
From: KLAERNER, GERRIT; BERMAN, LANCE
To: RELYPSA, INC.
Reel/Frame 031928/0703 →