IP Library Granted Patent US 10,709,678
Granted Patent B2
US 10,709,678 · App. 16/024,288 · Granted Jul 14, 2020

Methods of reducing risk of cardiovascular disease

Inventor: Charles L. Bisgaier (Ann Arbor, MI)
Assignee: NeuroBo Pharmaceuticals, Inc.
A61K31/194A61K45/06
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Quick Facts
Patent No.
US 10,709,678
App. No.
16/024,288
Granted
Jul 14, 2020
Kind
B2
Abstract

Methods of lowering the plasma LDL-C levels in a patient on a stable dose of statin where the patient has an LDL-C level above treatment goal. Methods of decreasing a patient's risk for developing coronary heart disease, having a recurrent cardiovascular event or reducing the severity of a secondary cardiovascular event, wherein the patient is on a stable dose of statin and the patient has an LDL-C level above treatment goal.

Claims (29)

1. A method of decreasing a patient's risk for developing coronary heart disease or having a recurrent cardiovascular event, comprising administering to the patient an effective amount of the compound:

or an ester, or a salt, or a hydrate thereof,

wherein the patient is on a stable dose of statin and requires additional lowering of LDL-C.

2. A method of preventing, delaying the onset of, or reducing the severity of a secondary cardiovascular event, comprising administering to a patient in need thereof, an effective amount of the compound:

or an ester, or a salt, or a hydrate thereof,

wherein the patient is on a stable dose of statin and requires additional lowering of LDL-C.

3. The method according to claim 1 , wherein the patient has an LDL-C level above treatment goal.

4. The method according to claim 3 , wherein the patient has coronary heart disease or a coronary heart risk equivalent, or has had a previous primary cardiovascular event, or a previous cerebral vascular event.

5. The method according to claim 4 , wherein the patient has one or more risk factors selected from the group consisting of smoking, hypertension, treatment with an antihypertensive medication, HDL cholesterol level less than 40 mg/dL, family history of premature coronary heart disease, male at least 45 years, and female at least 55 years.

6. The method according to claim 4 , wherein the patient has a 10-year risk for coronary heart disease of at least 10%.

7. The method according to claim 4 , wherein the patient's Framingham Risk Score is reduced by at least 1 point.

8. The method according to claim 4 , wherein the patient is diabetic.

9. The method according to claim 4 , wherein the patient has an HDL cholesterol level less than 40 mg/dL and a blood triglyceride levels at least 150 mg/dL.

10. The method according to claim 4 , wherein the patient is administered one or more additional cholesterol lowering drug independently selected from the group consisting of: a cholesterol absorption inhibitor, a bile acid sequestrant, a cholesteryl ester transfer protein inhibitor, a microsomal triglyceride transfer protein inhibitor, a PCSK9 inhibitor, a microRNA-33 inhibitor, a squalene synthase inhibitor and an apoB synthesis inhibitor.

11. The method according to claim 3 , wherein the compound is a calcium salt of gemcabene.

12. The method according to claim 3 , wherein the compound is the monocalcium salt of gemcabene.

13. The method according to claim 2 , wherein the patient has an LDL-C level above treatment goal.

14. The method according to claim 13 , wherein the patient has coronary heart disease or a coronary heart risk equivalent, or has had a previous primary cardiovascular event, or a previous cerebral vascular event.

15. The method according to 14 , wherein the patient has one or more risk factors selected from the group consisting of smoking, hypertension, treatment with an antihypertensive medication, HDL cholesterol level less than 40 mg/dL, family history of premature coronary heart disease, male at least 45 years, and female at least 55 years.

16. The method according to claim 14 , wherein the patient has a 10-year risk for coronary heart disease of at least 10%.

17. The method according to claim 14 , wherein the patient's Framingham Risk Score is reduced by at least 1 point.

18. The method according to claim 14 , wherein the patient is diabetic.

19. The method according to claim 14 , wherein the patient has an HDL cholesterol level less than 40 mg/dL and a blood triglyceride levels at least 150 mg/dL.

20. The method according to claim 14 , wherein the patient is administered one or more additional cholesterol lowering drug independently selected from the group consisting of: a cholesterol absorption inhibitor, a bile acid sequestrant, a cholesteryl ester transfer protein inhibitor, a microsomal triglyceride transfer protein inhibitor, a PCSK9 inhibitor, a microRNA-33 inhibitor, a squalene synthase inhibitor and an apoB synthesis inhibitor.

21. The method according to claim 13 , wherein the compound is a calcium salt of gemcabene.

22. The method according to claim 13 , wherein the compound is the monocalcium salt of gemcabene.

23. A method of decreasing a patient's Framingham Risk Score, comprising administering to a patient on a stable dose of a statin, an effective amount of the compound:

or the free acid, a salt, or a hydrate thereof,

wherein the patient's Framingham Risk Score is reduced by at least 1 point following the administration of the compound.

Assignments (3)
CHANGE OF NAME Recorded Mar 11, 2020
From: GEMPHIRE THERAPEUTICS INC.
To: NEUROBO PHARMACEUTICALS, INC.
Reel/Frame 052151/0108 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2018
From: BISGAIER, CHARLES L.
To: MICHIGAN LIFE THERAPEUTICS, LLC
Reel/Frame 046953/0043 →
MERGER Recorded Sep 24, 2018
From: MICHIGAN LIFE THERAPEUTICS, LLC
To: GEMPHIRE THERAPEUTICS INC.
Reel/Frame 046953/0098 →
Continuity (3)
Continuation 14370722
Provisional Application 61584002 · Jan 6, 2012
Related Publication 20180303779A1 · Oct 25, 2018