IP Library Granted Patent US 11,229,618
Granted Patent B2
US 11,229,618 · App. 16/197,924 · Granted Jan 25, 2022

Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy

Inventors: Ian Osterloh (Kent, GB); Pierre Wicker (Mystic, CT); Rene Braeckman (Richboro, PA); Paresh Soni (Mystic, CT); Mehar Manku (Birmingham, GB)
Assignee: Amarin Pharmaceuticals Ireland Limited
A61K31/202
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Quick Facts
Patent No.
US 11,229,618
App. No.
16/197,924
Granted
Jan 25, 2022
Kind
B2
Abstract

In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

Claims (9)

1. A method of increasing a ratio of omega-3 fatty acids to total fatty acids in plasma or RBCs of a subject having baseline fasting triglycerides of about 500 mg/dl to about 1500 mg/dl, a baseline ratio of omega-3 fatty acids to total fatty acids in plasma of about 2.0 to about 4.4 or a baseline ratio of omega-3 fatty acids to total fatty acids in RBCs of about 4.0 to about 8.4, and on stable statin therapy, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of EPA per day, wherein upon administering the composition to the subject daily for a period of 12 weeks, the subject exhibits an increase in the ratio of omega-3 fatty acids to total fatty acids in plasma and/or RBCs of at least 50% compared to a control subject on stable statin therapy without EPA, wherein the control subject also has baseline fasting triglycerides of about 500 mg/dl to about 1500 mg/dl.

2. The method of claim 1 , wherein the increase is at least about 60%.

3. The method of claim 1 , wherein the increase includes an increase in the ratio in plasma of at least 60%.

4. The method of claim 1 , wherein the increase includes an increase in the ratio in RBCs of at least 50%.

5. The method of claim 1 , wherein the omega-3 fatty acids include one or more of: α-linolenic acid, stearidonic acid, eicosatrienoic acid, eicosapentaenoic acid, ω-3 docosapentaenoic acid and docosahecaenoic acid.

6. The method of claim 1 , wherein the total fatty acids include one or more of: α-linolenic acid, stearidonic acid, eicosatrienoic acid, ω-3 arachidonic acid, eicosapentaenoic acid, ω-3 docosapentaenoic acid, docosahecaenoic acid, linoleic acid, γ-linolenic acid, eicosadienoic acid, dihomo-γ-linolenic acid, ω-6 arachidonic acid, adrenic acid, ω-6 docosapentaenoic acid, myristoleic acid, palmitoleic acid, cis-vaccenic acid, oleic acid, gondoic/gadoleic acid, erucic acid, nervonic acid, myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid and lignoceric acid.

7. The method of claim 1 , wherein the subject is administered about 2 g/day of EPA.

8. The method of claim 1 , wherein the subject is administered about 4 g/day of EPA.

9. The method of claim 1 , wherein the subject further exhibits no increase, no substantial increase, or a reduction in plasma and/or RBC levels of DHA compared to the control subject.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 17, 2021
From: BRAECKMAN, RENE; STIRTAN, WILLIAM; SONI, PARESH
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 057520/0242 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: OSTERLOH, IAN; WICKER, PIERRE; BRAECKMAN, RENE; SONI, PARESH; MANKU, MEHAR
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 049194/0320 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: MANKU, MEHAR; OSTERLOH, IAN; WICKER, PIERRE; BRAECKMAN, RENE; SONI, PARESH
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 049194/0349 →