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Last Updated: May 5, 2024

Claims for Patent: 10,912,751


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Summary for Patent: 10,912,751
Title:Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
Abstract: Disclosed herein are compositions comprising fixed doses of ETC-1002 and Ezetimibe. Also disclosed herein are methods for using fixed doses of ETC-1002 and Ezetimibe. Uses include methods of treating cardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.
Inventor(s): Newton; Roger Schofield (Ann Arbor, MI), Rosenberg; Noah Laban (Livingston, NJ), MacDougall; Diane Elaine (Lincoln, MA)
Assignee: Esperion Therapeutics, Inc. (Ann Arbor, MI)
Application Number:15/558,084
Patent Claims: 1. A method of treating familial hypercholesterolemia in a subject in need thereof, the method comprising administering a fixed-dosed combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe to the subject, wherein the fixed-dose combination comprises a fixed 180 milligram (mg) dose of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and a fixed 10 milligram (mg) dose of Ezetimibe.

2. The method of claim 1, wherein administering the fixed-dose combination decreases the level of LDL-C in the subject below that of a control subject receiving a placebo.

3. The method of claim 1, wherein administering the fixed-dose combination decreases the level of C-reactive protein (hsCRP) in the subject.

4. The method of claim 1, wherein administering the fixed-dose combination decreases the number of very low density lipoprotein in the subject.

5. The method of claim 1, wherein administering the fixed-dose combination reduces the risks of cardiovascular diseases in the subject.

6. The method of claim 1, wherein administering the fixed-dose combination decreases the level of LDL-C in the subject by at least 30% relative to baseline.

7. The method of claim 1, wherein administering the fixed-dose combination decreases the level of hsCRP in the subject by at least 26% relative to baseline.

8. The method of claim 1, wherein administering the fixed-dose combination decreases the level of hsCRP in the subject by at least 30% relative to baseline.

9. The method of claim 1, wherein the fixed-dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is administered once daily to the subject.

10. The method of claim 1, wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated to be a tablet.

11. The method of claim 1, wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated for oral delivery.

12. The method of claim 1, wherein the fixed dose combination of 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid and Ezetimibe is formulated for administration once daily.

13. The method of claim 1, wherein the subject is human.

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