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Methods of administering compositions comprising docosapentaenoic acid

a technology of compositions and docosapentaenoic acid, which is applied in the direction of drug compositions, metabolic disorders, cardiovascular disorders, etc., can solve the problems of failure in phase iii clinical development, insufficient reduction of ldl-cholesterol and tg by diet and single-drug therapy, and inability to infer the therapeutic effect of one composition at a given dos

Inactive Publication Date: 2014-04-10
MATINAS BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a pharmaceutical composition comprising eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in a ratio of no more than 1:1. The composition can be used to reduce lipid parameters such as triglycerides, total cholesterol, low density lipoprotein cholesterol, non-HDL cholesterol, and free fatty acids in a subject in need thereof. The composition can be administered to the subject in an amount of at least about 20 mg / day, alternatively at least about 30 mg / day, alternatively at least about 40 mg / day, alternatively at least about 50 mg / day, alternatively at least about 60 mg / day, alternatively at least about 70 mg / day, alternatively at least about 80 mg / day, alternatively at least about 90 mg / day, or alternatively at least about 100 mg / day. The composition can also contain no more than about 20% DHA or no more than about 15% DHA relative to the total amount of fatty acids present in the composition.

Problems solved by technology

The use of diet and single-drug therapy does not always decrease LDL-cholesterol and TG adequately enough to reach targeted values in patients with mixed dyslipidemia with or without a concomitant increase in triglycerides.
EPANOVA™ was previously under development for the treatment of Crohn's Disease but failed in phase III clinical development.
However, the effect of each specific omega-3 fatty acid composition may be different, and therefore the level of therapeutic effect of one composition at a given dose cannot necessarily be inferred from the level of therapeutic effects of other omega-3 fatty acid compositions at the same or similar dose.
In this same study, AMR101 slightly and non-significantly changed LDL-C while LOVAZA® shows a large significant increase in this same population, putting the latter at a disadvantage.
For example, high fasting triglycerides levels have been associated with an increased risk of myocardial infarction.

Method used

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  • Methods of administering compositions comprising docosapentaenoic acid
  • Methods of administering compositions comprising docosapentaenoic acid
  • Methods of administering compositions comprising docosapentaenoic acid

Examples

Experimental program
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Effect test

example 1

[0129]A composition according to the present prevention is prepared by mixing and homogenizing in a ratio of 98:2 the intermediates MEGAPEX E90D00EE (90% EPA ethyl ester,) and MAXOMEGA DPA95 FFA (≧95% DPA synthetic fatty acid produced from EPA ethyl ester concentrate) converted to ethyl ester, respectively. These intermediates were prepared and commercially offered for sale by Chemport Korea (MEGAPEX) and Equateq Ltd from Scotland, UK (MAXOMEGA). The relative amounts of fatty acids present in the starting intermediates and in the resulting novel composition are listed in Table 1 below. The resulting novel composition comprises 89.10% EPA, 1.95% DPA, 0.19% HPA, 91.24% omega-3-pentaenoic acids, less than 0.01% DHA, 91.24% omega-3-pentaenoic acids, 93.09% total omega-3 fatty acids, 3.15% ARA and 3.57% omega-6 fatty acids (all Area %).

TABLE 1Fatty acid Composition (Area %) of intermediatesand novel composition according to Example 198.0%2.0%MegapexMaxomegaNovelFatty AcidE90D00EEDPA95FFA...

example 2

[0130]A composition according to the present prevention is prepared by mixing and homogenizing in a ratio of 96:4 the intermediates MEGAPEX E90D00EE (90% EPA ethyl ester,) and MAXOMEGA DPA95 FFA (≧95% DPA synthetic fatty acid produced from EPA ethyl ester concentrate), converted to ethyl ester, respectively. These intermediates were prepared and commercially offered for sale by Chemport Korea (MEGAPEX) and Equateq Ltd from Scotland, UK (MAXOMEGA). The relative amounts of fatty acids present in the starting intermediates and in the resulting novel composition is listed in Table 2 below. The resulting novel composition comprises 87.28% EPA, 3.89% DPA, 0.18% HPA, 91.35% omega-3-pentaenoic acids, less than 0.01% DHA, 93.17% total omega-3 fatty acids and 3.49% omega-6 fatty acids (all Area %).

TABLE 2Fatty acid Composition (Area %) of intermediatesand novel composition according to Example 296.0%4.0%MegapexMaxomegaNovelFatty AcidE90D00EEDPA95FFA => EECompositionc18:00.0500.05c18:1n90.0600...

example 3

[0131]A composition according to the present prevention is prepared by mixing and homogenizing in a ratio of 94:6 the intermediates MEGAPEX E90D00EE (90% EPA ethyl ester,) and MAXOMEGA DPA95 FFA (≧95% DPA synthetic fatty acid produced from EPA ethyl ester concentrate) converted to ethyl ester, respectively. These intermediates were prepared and commercially offered for sale by Chemport Korea (MEGAPEX) and Equateq Ltd from Scotland, UK (MAXOMEGA). The relative amounts of fatty acids present in the starting intermediates and in the resulting novel composition are listed in table 3 below. The resulting novel composition comprises 85.46% EPA, 5.84% DPA, 0.18% HPA, 91.48% omega-3-pentaenoic acids, less than 0.01% DHA, 93.26% total omega-3 fatty acids, 3.02% ARA, and 3A2% omega-6 fatty acids (all Area %).

TABLE 3Fatty acid Composition (Area %) of intermediatesand novel composition according to Example 394.0%6.0%MegapexMaxomegaNovelFatty AcidE90D00EEDPA95FFA => EECompositionc18:00.0500.05c1...

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Abstract

The present invention relates to compositions comprising docosapentaenoic acid and methods of reducing lipid parameters, such as triglycerides, total cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, free fatty acids, and other lipids, comprising administration of omega-3 docosapentaenoic acid.

Description

RELATED APPLICATIONS[0001]This application is a continuation-in-part (CIP) application of PCT International Application No. PCT / US13 / 46176, filed on Jun. 17, 2013, which claims the benefit of U.S. Provisional Patent Application No. 61 / 660,757, filed Jun. 17, 2012, U.S. Provisional Patent Application No. 61 / 734,331, filed Dec. 6, 2012, and U.S. Provisional Patent Application No. 61 / 780,948, filed Mar. 13, 2013, the contents of which are incorporated herein by reference.FIELD OF INVENTION[0002]The present invention relates to a method comprising administration of docosapentaenoic acid compositions for the reduction of lipid parameters, such as triglycerides, total cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, free fatty acids, and other lipids. The present invention also relates to a method comprising administration of docosapentaenoic acid compositions for the increase of high density lipoprotein (HDL) cholesterol. The methods of the present invention m...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/232A61K31/202
CPCA61K31/202A61K31/232A61K31/40A61K9/4825A61K9/4858A61P3/06A61P9/00A61K2300/00A61K31/201
Inventor BOBOTAS, GEORGEFAWZY, ABDEL AZIZ
Owner MATINAS BIOPHARMA
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